CN113195022A - Systems, devices, and methods for analyte sensor insertion - Google Patents

Abstract

Systems, devices, and methods are provided for inserting at least a portion of an in vivo analyte sensor for sensing analyte levels in a bodily fluid of a subject. In particular, disclosed herein are various embodiments of applicators and components thereof designed to reduce trauma to tissue at the site of sensor insertion and increase the likelihood of successful sensor insertion. Embodiments for ensuring the structural integrity of the sensor are also disclosed.

Description

Systems, devices, and methods for analyte sensor insertion

Cross-referencing of related applications

This application claims priority and benefit of U.S. provisional patent application serial No. 62/784,074 filed on 12/21/2018, which is incorporated herein by reference in its entirety for all purposes.

Technical Field

The subject matter described herein relates generally to systems, devices, and methods for inserting at least a portion of an analyte sensor into a subject using an applicator.

Background

Detecting and/or monitoring analyte levels, such as glucose, ketones, lactate, oxygen, hemoglobin AIC, etc., is critical to the health of individuals with diabetes. Complications can occur in patients with diabetes, including loss of consciousness, cardiovascular disease, retinopathy, neuropathy, and nephropathy. A diabetic patient typically needs to monitor his or her glucose level to ensure that it remains within a clinically safe range, and may also use this information to determine if and/or when insulin is required to reduce the glucose level in his or her body, or when additional glucose is required to increase the glucose level in his or her body.

More and more clinical data indicate a strong correlation between glucose monitoring frequency and glycemic control. However, despite this correlation, many individuals diagnosed with diabetes do not monitor their glucose levels as frequently as they should be due to a combination of factors including convenience, caution in testing, pain and cost associated with glucose testing.

In order to increase patient compliance with frequent glucose monitoring programs, in vivo analyte monitoring systems may be utilized, wherein the sensor control device may be worn on the body of the individual requiring analyte monitoring. To increase the comfort and convenience of the individual, the sensor control device may have a small form factor and may be assembled and applied by the individual using the sensor applicator. The application process includes inserting at least a portion of a sensor that senses an analyte level of a user into a bodily fluid located in a human body layer using an applicator or insertion mechanism such that the sensor is in contact with the bodily fluid. The sensor control device may also be configured to transmit analyte data to another device from which the individual or her health care provider ("HCP") may view the data and make treatment decisions.

While current sensors may be convenient for the user, they are also prone to failure. These failures may be caused by user error, lack of proper training, poor user coordination, overly complicated operating procedures, physiological reactions to the inserted sensors, and other problems. For example, some prior art systems may be overly dependent on the precise assembly and deployment of the sensor control device and applicator by a single user. Other prior art systems may utilize a sharp insertion and retraction mechanism that is susceptible to trauma by tissue surrounding the sensor insertion site, which may result in inaccurate analyte level measurements. These challenges, and others described herein, can result in improper insertion of sensors and/or poor analyte measurement, and thus, failure to properly monitor the analyte levels of a patient.

Accordingly, there is a need for more reliable sensor insertion devices, systems, and methods that are easy to use by a patient and are not prone to error.

Disclosure of Invention

Exemplary embodiments of systems, devices, and methods for the assembly and use of applicators and sensor control devices for in vivo analyte monitoring systems are provided herein. The applicator may be provided to the user in sterile packaging containing the electronic housing of the sensor control device. According to some embodiments, a structure separate from the applicator, such as a container, may also be provided to the user as a sterile package containing the sensor module and the sharps module. A user may couple the sensor module to the electronics housing and may couple the spike to the applicator through an assembly process that involves inserting the applicator into the container in a specified manner. In other embodiments, the applicator, the sensor control device, the sensor module, and the sharp module may be provided in a single package. The applicator may be used to position the sensor control device on the person's body and to bring the sensor into contact with the body fluid of the wearer. Embodiments provided herein are improvements for preventing or reducing the likelihood of a sensor being improperly inserted or damaged or causing an adverse physiological response. Other improvements and advantages are also provided. Various configurations of these devices are described in detail by way of example embodiments only.

Other systems, devices, methods, features and advantages of the subject matter described herein will be or become apparent to one with skill in the art upon examination of the following figures and detailed description. It is intended that all such additional systems, devices, methods, features and advantages be included within this description, be within the scope of the subject matter described herein, and be protected by the accompanying claims. The features of the example embodiments should in no way be construed to limit the appended claims without explicitly stating those features in the claims.

Drawings

Structural and operational details of the subject matter set forth herein will become apparent upon study of the drawings, wherein like reference numerals refer to like parts. The components in the drawings are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the subject matter. Moreover, all illustrations are intended to convey concepts, where relative sizes, shapes and other detailed attributes may be illustrated schematically rather than literally or precisely.

Fig. 1 is a system overview of a sensor applicator, reader device, monitoring system, network and remote system.

Fig. 2A is a block diagram depicting an exemplary embodiment of a reader device.

Fig. 2B and 2C are block diagrams depicting exemplary embodiments of a sensor control device.

Fig. 3A-3G are progressive views of an exemplary embodiment of the assembly and application of the system of fig. 1 in conjunction with a two-piece architecture.

Fig. 4A is a side view depicting an exemplary embodiment of an applicator device coupled to a cap.

Fig. 4B is a side perspective view depicting an exemplary embodiment in which the applicator device and cap are decoupled.

Fig. 4C is a perspective view depicting an exemplary embodiment of an applicator device and a distal end of an electronics housing.

Fig. 5 is a proximal perspective view depicting an exemplary embodiment of a tray with a coupled antiseptic cap.

Fig. 6A is a proximal perspective cut-away view depicting an exemplary embodiment of a tray having a sensor transmission member.

Fig. 6B is a proximal perspective view depicting the sensor transmission member.

Fig. 7A is a side view depicting an exemplary embodiment of a housing.

Fig. 7B is a perspective view depicting an exemplary embodiment of a distal end of a housing.

Fig. 7C is a side cross-sectional view depicting an exemplary embodiment of a housing.

Fig. 8A is a side view depicting an exemplary embodiment of a sheath.

Fig. 8B is a perspective view depicting an exemplary embodiment of the proximal end of the sheath.

Fig. 8C is a close-up perspective view depicting an exemplary embodiment of the distal side of the pawl catch of the sheath.

Fig. 8D is a side view depicting an exemplary embodiment of a sheath feature.

Fig. 8E is an end view of an exemplary embodiment of the proximal end of the sheath.

Fig. 8F is a perspective view depicting an exemplary embodiment of a compressible distal end of an applicator.

Fig. 8G-8K are cross-sectional views depicting example geometries of embodiments of a compressible distal end of an applicator.

Fig. 8L is a perspective view of an exemplary embodiment of an applicator having a compressible distal end.

Fig. 8M is a cross-sectional view depicting an exemplary embodiment of an applicator having a compressible distal end.

Fig. 9A is a proximal perspective view depicting an exemplary embodiment of a sensor electronics carrier.

Fig. 9B is a distal perspective view depicting an exemplary embodiment of a sensor electronics carrier.

Fig. 10 is a proximal perspective view of an exemplary embodiment of a sharp carrier.

Fig. 11 is a side cross-sectional view depicting an exemplary embodiment of a sharp carrier.

Fig. 12A-12B are top and bottom perspective views, respectively, depicting an exemplary embodiment of a sensor module.

Fig. 13A and 13B are perspective and compression views, respectively, depicting an exemplary embodiment of a sensor connector.

FIG. 14 is a perspective view depicting an exemplary embodiment of a sensor.

Fig. 15A and 15B are bottom and top perspective views, respectively, of an exemplary embodiment of a sensor module assembly.

Fig. 16A and 16B are partial close-up views of an exemplary embodiment of a sensor module assembly.

Fig. 17A is a perspective view depicting an exemplary embodiment of a sharp module.

Fig. 17B is a perspective view depicting another exemplary embodiment of a sharp module.

Fig. 17C and 17D are side and perspective views depicting another exemplary embodiment of a sharp module.

Fig. 17E is a cross-sectional view depicting an exemplary embodiment of an applicator.

Fig. 17F is a flow chart depicting an exemplary embodiment method for disinfecting an applicator assembly.

Fig. 17G and 17H are photographs depicting an exemplary embodiment of a sharp tip.

Fig. 17I and 17J are perspective views depicting exemplary embodiments of a sharp module.

Fig. 18A is a cross-sectional view depicting an exemplary embodiment of an applicator.

Fig. 18B is an exploded view depicting various components of an exemplary embodiment of an applicator.

Fig. 19A is a cross-sectional view depicting an exemplary embodiment of an applicator during a deployment stage.

Fig. 19B and 19C are perspective views of exemplary embodiments of a sheath and a sensor electronics carrier, respectively.

Fig. 19D is a cross-sectional view depicting an exemplary embodiment of an applicator during a deployment stage.

Fig. 19E and 19F are perspective and partial close-up views, respectively, of an exemplary embodiment of a sheath-sensor electronics carrier assembly.

Fig. 19G is a cross-sectional view depicting an exemplary embodiment of an applicator during a deployment stage.

Fig. 19H and 19I are partial close-up views of an exemplary embodiment of a sheath sensor electronics carrier assembly.

Fig. 19J is a cross-sectional view depicting an exemplary embodiment of an applicator during a deployment stage.

Fig. 19K and 19L are partial close-up views of an exemplary embodiment of a sheath sensor electronics carrier assembly.

Fig. 20A-20G depict an exemplary embodiment of an applicator, where fig. 20A is a front perspective view of the embodiment, fig. 20B is a front side view of the embodiment, fig. 20C is a back side view of the embodiment, fig. 20D is a left side view of the embodiment, fig. 20E is a right side view of the embodiment, fig. 20F is a top view of the embodiment, and fig. 20G is a bottom view of the embodiment.

Fig. 21A to 21G depict another exemplary embodiment of an applicator, where fig. 21A is a front perspective view of the embodiment, fig. 21B is a front side view of the embodiment, fig. 21C is a rear side view of the embodiment, fig. 21D is a left side view of the embodiment, fig. 21E is a right side view of the embodiment, fig. 21F is a top view of the embodiment, and fig. 21G is a bottom view of the embodiment.

Fig. 22A to 22G depict an exemplary embodiment of a sensor control device, in which fig. 22A is a front perspective view of the embodiment, fig. 22B is a front side view of the embodiment, fig. 22C is a rear side view of the embodiment, fig. 22D is a left side view of the embodiment, fig. 22E is a right side view of the embodiment, fig. 22F is a top view of the embodiment, and fig. 22G is a bottom view of the embodiment.

Fig. 23A to 23G depict another exemplary embodiment of a sensor control device, in which fig. 23A is a front perspective view of the embodiment, fig. 23B is a front side view of the embodiment, fig. 23C is a rear side view of the embodiment, fig. 23D is a left side view of the embodiment, fig. 23E is a right side view of the embodiment, fig. 23F is a top view of the embodiment, and fig. 23G is a bottom view of the embodiment.

Fig. 24A to 24G depict another exemplary embodiment of a sensor control device, in which fig. 24A is a front perspective view of the embodiment, fig. 24B is a front side view of the embodiment, fig. 24C is a rear side view of the embodiment, fig. 24D is a left side view of the embodiment, fig. 24E is a right side view of the embodiment, fig. 24F is a top view of the embodiment, and fig. 24G is a bottom view of the embodiment.

Fig. 25A to 25G depict another exemplary embodiment of a sensor control device, in which fig. 25A is a front perspective view of the embodiment, fig. 25B is a front side view of the embodiment, fig. 25C is a rear side view of the embodiment, fig. 25D is a left side view of the embodiment, fig. 25E is a right side view of the embodiment, fig. 25F is a top view of the embodiment, and fig. 25G is a bottom view of the embodiment.

Fig. 26A to 26G depict another exemplary embodiment of a sensor control device, in which fig. 26A is a front perspective view of the embodiment, fig. 26B is a front side view of the embodiment, fig. 26C is a rear side view of the embodiment, fig. 26D is a left side view of the embodiment, fig. 26E is a right side view of the embodiment, fig. 26F is a top view of the embodiment, and fig. 26G is a bottom view of the embodiment.

Fig. 27A to 27G depict another exemplary embodiment of a sensor control device, in which fig. 27A is a front perspective view of the embodiment, fig. 27B is a front side view of the embodiment, fig. 27C is a rear side view of the embodiment, fig. 27D is a left side view of the embodiment, fig. 27E is a right side view of the embodiment, fig. 27F is a top view of the embodiment, and fig. 27G is a bottom view of the embodiment.

Fig. 28A to 28G depict another exemplary embodiment of a sensor control device, in which fig. 28A is a front perspective view of the embodiment, fig. 28B is a front side view of the embodiment, fig. 28C is a rear side view of the embodiment, fig. 28D is a left side view of the embodiment, fig. 28E is a right side view of the embodiment, fig. 28F is a top view of the embodiment, and fig. 28G is a bottom view of the embodiment.

Fig. 29A to 29G depict another exemplary embodiment of a sensor control device, in which fig. 29A is a front perspective view of the embodiment, fig. 29B is a front side view of the embodiment, fig. 29C is a rear side view of the embodiment, fig. 29D is a left side view of the embodiment, fig. 29E is a right side view of the embodiment, fig. 29F is a top view of the embodiment, and fig. 29G is a bottom view of the embodiment.

Fig. 30A-30G depict an exemplary embodiment of an applicator, where fig. 30A is a front perspective view of the embodiment, fig. 30B is a front side view of the embodiment, fig. 30C is a back side view of the embodiment, fig. 30D is a left side view of the embodiment, fig. 30E is a right side view of the embodiment, fig. 30F is a top view of the embodiment, and fig. 30G is a bottom view of the embodiment.

Fig. 31A to 31G depict another exemplary embodiment of an applicator, where fig. 31A is a front perspective view of the embodiment, fig. 31B is a front side view of the embodiment, fig. 31C is a rear side view of the embodiment, fig. 31D is a left side view of the embodiment, fig. 31E is a right side view of the embodiment, fig. 31F is a top view of the embodiment, and fig. 31G is a bottom view of the embodiment.

Fig. 32A to 32G depict an exemplary embodiment of a sensor control device, in which fig. 32A is a front perspective view of the embodiment, fig. 32B is a front side view of the embodiment, fig. 32C is a rear side view of the embodiment, fig. 32D is a left side view of the embodiment, fig. 32E is a right side view of the embodiment, fig. 32F is a top view of the embodiment, and fig. 32G is a bottom view of the embodiment.

Fig. 33A to 33G depict another exemplary embodiment of a sensor control device, in which fig. 33A is a front perspective view of the embodiment, fig. 33B is a front side view of the embodiment, fig. 33C is a rear side view of the embodiment, fig. 33D is a left side view of the embodiment, fig. 33E is a right side view of the embodiment, fig. 33F is a top view of the embodiment, and fig. 33G is a bottom view of the embodiment.

Fig. 34A to 34G depict another exemplary embodiment of a sensor control device, in which fig. 34A is a front perspective view of the embodiment, fig. 34B is a front side view of the embodiment, fig. 34C is a rear side view of the embodiment, fig. 34D is a left side view of the embodiment, fig. 34E is a right side view of the embodiment, fig. 34F is a top view of the embodiment, and fig. 34G is a bottom view of the embodiment.

Fig. 35A to 35G depict another exemplary embodiment of a sensor control device, where fig. 35A is a front perspective view of the embodiment, fig. 35B is a front side view of the embodiment, fig. 35C is a rear side view of the embodiment, fig. 35D is a left side view of the embodiment, fig. 35E is a right side view of the embodiment, fig. 35F is a top view of the embodiment, and fig. 35G is a bottom view of the embodiment.

Detailed Description

Before the present subject matter is described in detail, it is to be understood that this disclosure is not limited to particular embodiments described, as such may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting, since the scope of the present disclosure will be limited only by the appended claims.

As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise.

The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present disclosure is not entitled to antedate such publication by virtue of prior disclosure. Further, the release date provided may be different from the actual release date, which may require independent confirmation.

In general, embodiments of the present disclosure include systems, devices, and methods for inserting an applicator using an analyte sensor for use with in vivo analyte monitoring systems. Thus, many embodiments include an in vivo analyte sensor structurally configured such that at least a portion of the sensor is positioned or positionable in a body of a user to obtain information about at least one analyte of the body. It should be noted, however, that the embodiments disclosed herein are used with in vivo analyte monitoring systems that incorporate in vitro capabilities, as well as in vitro or in vitro analyte monitoring systems, including systems that are completely non-invasive.

Moreover, for each embodiment of the methods disclosed herein, systems and apparatuses capable of performing each of those embodiments are covered within the scope of this disclosure. For example, embodiments of sensor control devices are disclosed and these devices may have one or more sensors, analyte monitoring circuitry (e.g., analog circuitry), memory (e.g., for storing instructions), power supplies, communication circuitry, transmitters, receivers, processors, and/or controllers (e.g., for executing instructions) that may perform or facilitate the performance of any and all method steps. These sensor control device embodiments may be used and can be used to implement those steps performed by the sensor control device according to any and all of the methods described herein.

As described above, various embodiments of systems, devices, and methods are described herein that provide for improved assembly and use of analyte sensor insertion devices for in vivo analyte monitoring systems. In particular, several embodiments of the present disclosure are designed to improve sensor insertion methods with respect to in vivo analyte monitoring systems, and in particular, to minimize trauma to the insertion site during the sensor insertion process. For example, some embodiments include a powered sensor insertion mechanism configured to operate at a higher controlled speed relative to a manual insertion mechanism in order to reduce trauma to the insertion site. In other embodiments, an applicator having a compressible distal end can stretch and flatten the skin surface at the insertion site, and thus, the likelihood of insertion failure due to skin sagging can be reduced. In still other embodiments, a sharp with an offset tip, or a sharp made with a plastic material or a casting manufacturing process, may also reduce trauma to the insertion site. In summary, these embodiments may increase the likelihood of successful sensor insertion and reduce the amount of trauma at the insertion site, to name a few advantages.

Before describing these aspects of the embodiments in detail, it is first necessary to describe examples of devices that may be present, for example, in an in vivo analyte monitoring system, and examples of their operation, all of which may be used with the embodiments described herein.

There are various types of in vivo analyte monitoring systems. For example, a "continuous analyte monitoring" system (or a "continuous glucose monitoring" system) may continuously send data from the sensor control device to the reader device without automatic prompting, e.g., according to a schedule. As another example, a "flash memory analyte monitoring" system (or "flash memory glucose monitoring" system or simply "flash memory" system) is an in-vivo system that can transmit data from a sensor control device in response to a request for a scan or data by a reader device, for example using Near Field Communication (NFC) or Radio Frequency Identification (RFID) protocols. The in vivo analyte monitoring system may also operate without fingerstick calibration.

In vivo analyte monitoring systems are distinguished from "in vitro" systems that contact a biological sample (or "ex vivo") outside the body and typically include a meter device having a port for receiving an analyte test strip carrying a user's bodily fluids, which can be analyzed to determine the user's blood glucose level.

In vivo monitoring systems may include sensors that, when positioned in vivo, come into contact with a body fluid of a user and sense the levels of analytes contained therein. The sensor may be part of a sensor control device that resides on the user's body and contains electronics and a power source to enable and control analyte sensing. The sensor control device and its variants may also be referred to as a "sensor control unit," an "on-body electronics" device or unit, an "on-body" device or unit, or a "sensor data communication" device or unit, to name a few.

The in vivo monitoring system may also include a device that receives sensed analyte data from the sensor control device and processes and/or displays the sensed analyte data to a user in any number of forms. Such devices and variations thereof may be referred to as "handheld reader devices," "reader devices" (or simply "readers"), "handheld electronics" (or simply "handheld devices"), "portable data processing" devices or units, "data receivers," "receiver" devices or units (or simply receivers), or "remote" devices or units, to name a few. Other devices such as personal computers have also been used with or incorporated into in vivo and in vitro monitoring systems.

Exemplary embodiments of in vivo analyte monitoring systems

Fig. 1 is a conceptual diagram depicting an exemplary embodiment of an analyte monitoring system 100, the analyte monitoring system 100 including a sensor applicator 150, a sensor control device 102, and a reader device 120. Here, the sensor applicator 150 may be used to deliver the sensor control device 102 to a monitoring location on the user's skin where the sensor 104 is held in place by the adhesive patch 105 for a period of time. Sensor control device 102 is further described in fig. 2B and 2C, and may communicate with reader device 120 via communication path 140 using wired or wireless technology. Example wireless protocols include bluetooth, bluetooth low energy (BLE, BTLE, bluetooth smart, etc.), Near Field Communication (NFC), etc. The user can use screen 122 and input 121 to monitor applications installed in memory on reader device 120 and can recharge the device battery using power port 123. Although only one reader device 120 is shown, the sensor control device 102 may communicate with multiple reader devices 120. Each reader device 120 may communicate and share data with each other. More details regarding reader device 120 will be set forth below with respect to fig. 2A. Reader device 120 may communicate with local computer system 170 via communication path 141 using a wired or wireless communication protocol. The local computer system 170 may include one or more of a laptop, desktop, tablet, smartphone, set-top box, video game console, and other computing device, and the wireless communication may include any one of a number of suitable wireless networking protocols, including bluetooth, bluetooth low energy (BTLE), Wi-Fi, or others. As previously described, local computer system 170 may communicate with network 190 via communication path 143 via a wired or wireless communication protocol, similar to the manner in which reader device 120 may communicate with network 190 via communication path 142. The network 190 may be any of a number of networks, such as private and public networks, local or wide area networks, and so forth. The trusted computer system 180 may include a server and may provide authentication services and secure data storage and may communicate with the network 190 via the communication path 144 through wired or wireless techniques.

Exemplary embodiments of reader devices

Fig. 2 is a block diagram depicting an exemplary embodiment of a reader device 120 configured as a smartphone. Here, the reader device 120 may include a display 122, an input component 121, and a processing core 206, the processing core 206 including a communication processor 222 coupled with a memory 223 and an application processor 224 coupled with a memory 225. A separate memory 230, an RF transceiver 228 having an antenna 229, and a power supply 226 having a power management module 238 may also be included. In addition, the reader device 120 may also include a multi-function transceiver 232 that may communicate with the antenna 234 through Wi-Fi, NFC, Bluetooth, BTLE, and GPS. These components are electrically and communicatively coupled in a manner that creates a functional device, as will be appreciated by those skilled in the art.

Exemplary embodiments of a sensor control device

Fig. 2B and 2C are block diagrams depicting an example implementation of a sensor control device 102 having an analyte sensor 104 and sensor electronics 160 (including analyte monitoring circuitry), which sensor control device 102 may have most of the processing power for presenting final result data suitable for display to a user. In fig. 2B, a single semiconductor chip 161 is depicted, and the single semiconductor chip 161 may be a custom Application Specific Integrated Circuit (ASIC). Certain high-level functional units are shown in ASIC 161, including an Analog Front End (AFE)162, power management (or control) circuitry 164, a processor 166, and communication circuitry 168 (which may be implemented as a transmitter, receiver, transceiver, passive circuitry, or otherwise according to a communication protocol). In this embodiment, both the AFE162 and the processor 166 serve as analyte monitoring circuitry, but in other embodiments either circuit may perform the analyte monitoring function. The processor 166 may include one or more processors, microprocessors, controllers, and/or microcontrollers, each of which may be a separate chip or distributed among (or part of) a plurality of different chips.

Memory 163 is also included within ASIC 161 and may be shared by various functional units present within ASIC 161, or may be distributed between two or more of them. The memory 163 may also be a separate chip. The memory 163 may be volatile and/or nonvolatile memory. In this embodiment, the ASIC 161 is coupled to a power source 170, and the power source 170 may be a button cell battery or the like. The AFE162 interfaces with and receives measurement data from the in vivo analyte sensor 104 and outputs the data in digital form to the processor 166, which in turn processes the data to arrive at the final resulting glucose discrete and trend values, etc. This data may then be provided to the communication circuitry 168, via the antenna 171, and transmitted to the reader device 120 (not shown), for example, where a resident software application requires minimal further processing to display the data.

Fig. 2C is similar to fig. 2B, but instead of including two separate semiconductor chips 162 and 174, semiconductor chips 162 and 174 may be packaged together or separately. Here, the AFE162 resides on the ASIC 161. Processor 166 is integrated with power management circuitry 164 and communication circuitry 168 on chip 174. AFE162 includes memory 163 and chip 174 includes memory 165, where memory 165 may be isolated or distributed. In an exemplary embodiment, AFE162 is combined with power management circuitry 164 and processor 166 on one chip, while communication circuitry 168 is on a separate chip. In another exemplary embodiment, the AFE162 and the communication circuitry 168 are both on one chip, while the processor 166 and the power management circuitry 164 are on another chip. It should be noted that other chip combinations are possible, including three or more chips, each chip taking responsibility for the individual functions described, or sharing one or more functions for fail-safe redundancy.

Example embodiments of an Assembly Process for a sensor control device

According to some embodiments, the components of the sensor control device 102 may be acquired by the user in multiple packages, requiring the user to final assemble before delivery to the appropriate user location. Fig. 3A-3E depict an exemplary embodiment of an assembly process for the sensor control device 102 by a user, including preparing separate components prior to coupling the components in order to prepare the sensor for delivery. In other embodiments, such as those described with respect to fig. 17B-17F, the components of the sensor control apparatus 102 and the applicator 150 may be acquired by a user in a single package. Fig. 3F-3G depict exemplary embodiments of delivering the sensor control device 102 to an appropriate user location by selecting an appropriate delivery location and applying the device 102 to that location.

Fig. 3A depicts a sensor container or tray 810 with a removable lid 812. The user prepares the sensor tray 810 by removing the cover 812, the cover 812 acting as a sterile barrier to protect the internal contents of the sensor tray 810 and otherwise maintain a sterile internal environment. The removal cover 812 exposes a platform 808 located within the sensor tray 810, and the plug assembly 207 (partially visible) is disposed within the platform 808 and otherwise strategically embedded within the platform 808. The plug assembly 207 includes a sensor module (not shown) and a sharps module (not shown). The sensor module carries the sensor 104 (fig. 1) and the sharps module carries an associated sharps for assisting in transcutaneous transfer of the sensor 104 under the skin of the user during application of the sensor control device 102 (fig. 1).

Fig. 3B depicts the sensor applicator 150 and the user prepares the sensor applicator 150 for final assembly. The sensor applicator 150 includes a housing 702, one end of the housing 702 being sealed with an applicator cap 708. In some embodiments, for example, an O-ring or another type of sealing gasket may seal the interface between the housing 702 and the applicator cap 708. In at least one embodiment, an O-ring or sealing gasket can be molded onto one of the housing 702 and the applicator cap 708. The applicator cap 708 provides a barrier that protects the internal contents of the sensor applicator 150. Specifically, the sensor applicator 150 contains an electronics housing (not shown) that holds electrical components for the sensor control device 102 (fig. 1), and the applicator cap 708 may or may not maintain a sterile environment for the electrical components. Preparation of the sensor applicator 150 includes decoupling the housing 702 from the applicator cap 708, which may be accomplished by unscrewing the applicator cap 708 from the housing 702. The applicator cap 708 can then be discarded or otherwise set aside.

Fig. 3C depicts a user inserting the sensor applicator 150 into the sensor tray 810. The sensor applicator 150 includes a shroud 704, the shroud 704 configured to be received by the platform 808 to temporarily unlock the shroud 704 relative to the housing 702, and also to temporarily unlock the platform 808 relative to the sensor tray 810. Advancing the housing 702 into the sensor tray 810 causes the plug assembly 207 (fig. 3A) disposed within the sensor tray 810 (which includes the sensor and the sharps module) to couple to an electronics housing disposed within the sensor applicator 150.

In fig. 3D, the user removes the sensor applicator 150 from the sensor tray 810 by proximally retracting the housing 702 relative to the sensor tray 810.

Fig. 3E depicts the bottom or interior of the sensor applicator 150 after removal from the sensor tray 810 (fig. 3A and 3C). The sensor applicator 150 is removed from the sensor tray 810 with the sensor control device 102 fully assembled therein and positioned for transfer to a target monitoring location. As shown, the sharp 2502 extends from the bottom of the sensor control device 102 and carries a portion of the sensor 104 within its hollow or recessed portion. The sharp 2502 is configured to penetrate the skin of a user, thereby contacting the sensor 104 with bodily fluids.

Fig. 3F and 3G depict exemplary transfers of the sensor control device 102 to a target monitoring location 221, such as the back of a user's arm. Fig. 3F shows the user advancing the sensor applicator 150 towards the target monitoring location 221. When the skin is engaged at the target monitoring location 221, the sheath 704 is retracted into the housing 702, which allows the sensor control apparatus 102 (fig. 3E and 3G) to advance into engagement with the skin. With the aid of the sharp 2502 portion (fig. 3E), the sensor 104 (fig. 3E) is advanced percutaneously into the patient's skin at the target monitoring location 221.

Fig. 3G shows the user retracting the sensor applicator 150 from the target monitoring position 221 with the sensor control device 102 successfully attached to the user's skin. An adhesive patch 105 (fig. 1) applied to the bottom of the sensor control device 102 adheres to the skin to secure the sensor control device 102 in place. When the housing 702 is fully advanced at the target monitoring location 221, the sharp 2502 (fig. 3E) automatically retracts, while the sensor 104 (fig. 3E) remains in position to measure the analyte level.

According to some embodiments, as described with respect to fig. 3A-3G and elsewhere herein, the system 100 may provide opportunities to reduce or eliminate accidental damage, permanent deformation, or improper assembly of applicator components as compared to prior art systems. Since the applicator housing 702 directly engages the platform 808 when the boot 704 is unlocked, rather than indirectly via the boot 704, the relative angle between the boot 704 and the housing 702 will not cause damage or permanent deformation of the arm or other components. The likelihood of relatively high forces during assembly (as in conventional devices) will be reduced, which in turn reduces the chance of unsuccessful assembly by the user. Further details regarding the implementation of the applicator, its components, and variations thereof are described in U.S. patent publication nos. 2013/0150691, 2016/0331283, and 2018/0235520, all of which are hereby incorporated by reference in their entirety for all purposes.

Exemplary implementations of sensor applicator devices(Mode)

Fig. 4A is a side view depicting an exemplary embodiment of the applicator device 150 coupled with a nut 708. This is one example of how the applicator 150 may be shipped to and received by a user prior to assembly with the sensor. In other embodiments, the applicator 150 may be delivered to the user, including the sensor and the sharp. Fig. 4B is a side perspective view depicting the applicator 150 and the cap 708 after decoupling. Fig. 4C is a perspective view depicting an exemplary embodiment of the distal end of the applicator device 150, wherein, when the cap 708 is in place, the electronics housing 706 and the adhesive patch 105 are removed from their positions that would otherwise be retained within the sensor electronics carrier 710 of the sheath 704.

Exemplary embodiments of a tray and sensor Module Assembly

Fig. 5 is a proximal perspective view depicting an exemplary embodiment of a tray 810 having a sterile cover 812 removably coupled thereto, wherein in some embodiments it may be indicated how the package is shipped to and received by a user prior to assembly.

Fig. 6A is a proximal perspective cut-away view depicting a sensor transmission member within a tray 810 according to some embodiments. Platform 808 is slidably coupled within tray 810. The desiccant 502 is fixed relative to the tray 810. The sensor module 504 is mounted within a tray 810.

Fig. 6B is a proximal perspective view depicting an exemplary embodiment of the sensor module 504 in greater detail. Here, the retaining arm extensions 1834 of the platform 808 releasably secure the sensor module 504 in place. The module 2200 is coupled with the connector 2300, the sharps module 2500, and the sensor (not shown) such that it can be removed together as the sensor module 504 during assembly.

Exemplary embodiments of the applicator housing

Fig. 7A is a side view illustrating an exemplary embodiment of an applicator housing 702, the applicator housing 702 may include an internal cavity with a support structure for applicator functions. The user may push the housing 702 in the distal direction to initiate the applicator assembly process and then also cause the sensor control device 102 to pass, after which the cavity of the housing 702 may act as a receiver for the sharp portion. In an exemplary embodiment, various features are shown including a housing orientation feature 1302, the housing orientation feature 1302 being used to orient the device during assembly and use. Tamper ring groove 1304 may be a recess located around the outer circumference of housing 702 at the distal end of tamper ring protector 1314 and the proximal end of tamper ring holder 1306. The tamper-evident ring groove 1304 may hold a tamper-evident ring so that a user can identify whether the device has been tampered with or otherwise used. The housing threads 1310 may secure the housing 702 to complementary threads on the cap 708 (fig. 4A and 4B) by aligning with the complementary cap threads and rotating in a clockwise or counterclockwise direction. The side grip area 1316 of the housing 702 may provide an exterior surface location at which a user may grip the housing 702 for use. Grip tabs 1318 are ridges that are slightly raised relative to side grip regions 1316, which may help facilitate easy removal of housing 702 from cap 708. The shark teeth 1320 may be raised portions with flat sides on the clockwise edge to shear off the tamper ring (not shown) and hold the tamper ring in place after the user unscrews the cap 708 and the housing 702. In the exemplary embodiment, four shark teeth 1320 are used, although more or less shark teeth 1320 may be used as desired.

Fig. 7B is a perspective view depicting the distal end of the housing 702. Here, three of the housing guide structures (or "guide ribs") 1321 are angled at 120 degrees relative to each other and at 60 degrees relative to the locking structure (or "locking rib") 1340, three of which are also angled at 120 degrees relative to each other. Other angular orientations, symmetrical or asymmetrical, may be used, as well as any number of one or more structures 1321 and 1340. Here, each structure 1321 and 1340 is configured as a planar rib, although other shapes may be used. Each guide rib 1321 includes a guide edge (also referred to as a "jacket rail") 1326 that can pass along a surface of the jacket 704 (e.g., rail 1418 described with reference to fig. 8A). Insertion hard stop 1322 may be a distally facing flat surface of housing guide rib 1321 located near the proximal end of housing guide rib 1321. Insertion of the hard stop 1322 provides a surface for the sensor electronics carrier travel limiting face 1420 of the sheath 704 (fig. 8B) to abut during use, preventing further movement of the sensor electronics carrier travel limiting face 1420 in the proximal direction. During assembly, carrier interface post 1327 passes through aperture 1510 (fig. 9A) of sensor electronics carrier 710. The sensor electronics carrier interface 1328 may be a rounded, distal-facing surface of the housing guide rib 1321, the housing guide rib 1321 interfacing with the sensor electronics carrier 710.

Fig. 7C is a side cross-sectional view illustrating an exemplary embodiment of a housing. In an exemplary embodiment, the side cross-sectional profiles of the housing guide ribs 1321 and the locking ribs 1340 are shown. Locking ribs 1340 include sheath snap introduction features 1330 near the distal end of locking ribs 1340 that flare distally outward from a central axis 1346 of housing 702. As sheath 704 moves toward the proximal end of housing 702, each sheath snap introduction feature 1330 causes detent snap circles 1404 of detent snaps 1402 of sheath 704, as shown in fig. 8C, to flex inward toward central axis 1346. Once past the distal point of sheath snap introduction feature 1330, detent snap 1402 of sheath 704 is locked in place in locking slot 1332. Thus, the pawl catch 1402 cannot easily move in the distal direction, shown in FIG. 8C as pawl catch plane 1406, due to the surface having a plane perpendicular to the vicinity of the central axis 1346.

As the housing 702 is moved further proximally toward the skin surface, and as the sheath 704 is advanced distally of the housing 702, the detent catch 1402 moves into the unlocking slot 1334 and the applicator 150 is in the "armed" position ready for use. When the user further applies a force to the proximal end of the housing 702, the pawl catch 1402 passes the firing pawl 1344 while pressing the sheath 704 against the skin. As the firing sequence begins due to the release of energy stored in the deflected detent catch 1402, the detent catch 1402 moves in a proximal direction relative to the skin surface toward the sheath stop ramp 1338, the sheath stop ramp 1338 splays slightly outward relative to the central axis 1346, and slows the movement of the sheath 704 during the firing sequence. After unlocking slot 1334, the next slot encountered by detent catch 1402 is the final locking slot 1336, into which final locking slot 1336 detent catch 1402 enters at the end of the stroke or racking sequence performed by the user. Finally, locking slot 1336 may be a proximally facing surface perpendicular to central axis 1346 that engages pawl catch plane 1406 after passage of pawl catch 1402 and prevents reuse of the device by holding sheath 704 firmly in place relative to housing 702. Insertion hard stop 1322 of housing guide rib 1321 prevents sheath 704 from advancing proximally relative to housing 702 by engaging sensor electronics carrier travel limit surface 1420.

Exemplary embodiments of an applicator sheath

Fig. 8A and 8B are side and perspective views, respectively, depicting an exemplary embodiment of a sheath 704. In this exemplary embodiment, the sheath 704 may place the sensor control device 102 over the user's skin surface prior to application. The sheath 704 may also contain features to help hold the sharp in the application position of the appropriate sensor, determine the force required for sensor application, and guide the sheath 704 relative to the housing 702 during application. Detent catch 1402 is near the proximal end of sheath 704, as further described below with reference to FIG. 8C. The sheath 704 may have a generally cylindrical cross-section with a first radius in a proximal portion (closer to the top of the figure) that is shorter than a second radius in a distal portion (closer to the bottom of the figure). Also shown are a plurality of detent gaps 1410, three in this exemplary embodiment. Sheath 704 can include one or more detent gaps 1410, each of which can be a cut-out with space for sheath snap introduction feature 1330 to pass distally through until the distal surface of locking rib 1340 contacts the proximal surface of detent gap 1410.

Guide 1418 is disposed between sensor electronics carrier travel limit surface 1420 at the proximal end of sheath 704 and the cutout surrounding locking arm 1412. Each guide track 1418 can be a channel between two ridges, wherein a leading edge 1326 of the housing guide rib 1321 can slide distally relative to the sheath 704.

Locking arm 1412 is disposed near the distal end of sheath 704 and may include an attached distal end and a free proximal end, which may include a locking arm interface 1416. When locking arm interface 1416 of locking arm 1412 engages locking interface 1502 of sensor electronics carrier 710, locking arm 1412 may lock sensor electronics carrier 710 to enclosure 704. Locking arm reinforcing ribs 1414 may be disposed near the center of each locking arm 1412 and may serve as reinforcing points for otherwise weak points of each locking arm 1412 to prevent excessive bending or damage to the locking arms 1412.

The pawl catch enhancement feature 1422 may be positioned along a distal portion of the pawl catch 1402 and may provide reinforcement to the pawl catch 1402. Alignment notch 1424 may be a cut-out near the distal end of sheath 704 that provides an opening for a user to align with the sheath orientation feature of platform 808. The reinforcement rib 1426 may include a support, here triangular in shape, that provides support for the pawl base 1436. The housing guide track gap 1428 may be a cutout for the distal surface of the housing guide rib 1321 to slide during use.

Fig. 8C is a close-up perspective view depicting an exemplary embodiment of detent catch 1402 of sheath 704. Pawl catch 1402 may include pawl catch bridge 1408 near or at its proximal end. Pawl catch 1402 may also include a pawl catch plane 1406 on a distal side of pawl catch bridge 1408. The outer surface of the pawl catch bridge 1408 may include a pawl catch circle 1404, the pawl catch circle 1404 being a rounded surface that allows the pawl catch bridge 1408 to move more easily on the inner surface of the housing 702 (e.g., the locking ribs 1340).

Fig. 8D is a side view depicting an exemplary embodiment of a sheath 704. Here, the alignment notch 1424 may be relatively close to the pawl gap 1410. Detent gaps 1410 are located at relatively proximal locations on the distal portion of the sheath 704.

Fig. 8E is an end view depicting an exemplary embodiment of the proximal end of the sheath 704. Here, the rear wall for the guide rail 1446 may provide a passage slidably coupled with the housing guide rib 1321 of the housing 702. The sheath rotation limiter 1448 may be a notch that reduces or prevents rotation of the sheath 704.

Fig. 8F is a perspective view depicting an exemplary embodiment of a compressible distal end 1450 that can be attached and/or detached from the sheath 704 of the applicator 150. In a general sense, the embodiments described herein operate by flattening and stretching the skin surface at predetermined locations for sensor insertion. In addition, embodiments described herein may also be used for other medical applications, such as transdermal drug delivery, needle injection, wound closure suturing, device implantation, application of adhesive surfaces to the skin, and other similar applications.

By way of background, those skilled in the art will appreciate that skin is a highly anisotropic tissue from a biomechanical point of view and varies greatly from individual to individual. This may affect the extent to which communication may be performed between the underlying tissue and the surrounding environment, for example, with respect to the rate of drug diffusion, the ability to penetrate the skin with a sharp tip, or the ability of the sensor to be inserted into the body at a sharply guided insertion site.

In particular, embodiments described herein aim to reduce the anisotropic properties of the skin in predetermined areas by flattening and stretching the skin and thereby improve the aforementioned applications. Smoothing the skin (e.g., smoothing to remove wrinkles) before mating with a similar shape (e.g., a flat, circular adhesive pad of a sensor control unit) may result in a more consistent surface area contact interface. More consistent contact (or drug dosage) may be achieved when the surface contour of the skin approaches the contour specification of the design surface of the device (or, for example, the design contact area for drug delivery). It is also advantageous for the wearable adhesive to be able to wear by making a continuous contact of the adhesive with the skin in a predetermined area without wrinkles. Other advantages may include (1) increased wear duration for devices that rely on skin adhesion to function, and (2) more predictable skin contact area, which will improve dosing in transdermal drug/drug delivery.

Furthermore, skin smoothing (e.g., as a result of tissue compression) in combination with stretching can reduce the viscoelastic properties of the skin and increase its stiffness, which in turn can increase the success rate of sensor placement and function associated with sharps.

With respect to insertion of the sensor, a puncture wound can cause early signal distortion (ESA) in the sensor and can be mitigated when the skin has been flattened and rigidly stretched. Some known methods of minimizing puncture wounds include: (1) reducing the size of the introducer, or (2) limiting the length of the needle inserted into the body. However, these known methods may reduce the insertion success rate due to skin compliance. For example, when the sharp tip contacts the skin, the skin deforms inward into the body before the tip penetrates the skin, a phenomenon also known as "skin sag". If the sharp portion is not sufficiently stiff due to a small cross-sectional area and/or not long enough, the sharp portion may not create a large enough insertion point or may not be located in the desired position due to deflection to allow the sensor to pass through the skin and be properly positioned. The degree of skin sagging can vary between subjects and within subjects, meaning that the distance between the sharp and the skin surface can vary for different insertion situations. Reducing this variation by stretching and flattening the skin may allow for a more accurately functioning and consistent sensor insertion mechanism.

Referring to fig. 8F, a perspective view depicts an exemplary embodiment of a compressible distal end 1450 of the applicator 150. According to some embodiments, compressible distal end 1450 may be fabricated from an elastomeric material. In other embodiments, compressible distal end 1450 can be made of metal, plastic, composite legs or springs, or a combination thereof.

In some embodiments, compressible distal end 1450 can be detached from applicator 150 and used with various other similar or different applicators or medical devices. In other embodiments, compressible distal end 1450 can be manufactured as part of sheath 704. In still other embodiments, the compressible distal end 1450 may be attached to other portions of the applicator 150 (e.g., a sensor electronics carrier) or, alternatively, may be used as a separate stand-alone device. Further, although compressible distal end 1450 is shown in fig. 8F and 8G as having a continuous ring geometry, other configurations may be utilized. For example, fig. 8H-8K are cross-sectional views depicting various exemplary compressible distal ends having an octagonal geometry 1451 (fig. 8H), a star geometry 1452 (fig. 8I), a non-continuous annular geometry 1453 (fig. 8J), and a non-continuous rectangular geometry (fig. 8K). With respect to fig. 8J and 8K, a compressible distal end having a non-continuous geometry will have a plurality of points or spans to contact a predetermined area of skin. Those skilled in the art will recognize that other geometries are possible and are well within the scope of the present disclosure.

Fig. 8L and 8M are perspective and cross-sectional views, respectively, depicting an applicator 150 having a compressible distal end 1450. As shown in fig. 8L and 8M, the applicator 150 may further include an applicator housing 702, a sheath 704 to which a compressible distal end 1450, a sharp 2502, and a sensor 104 are attached.

According to some embodiments, in operation, the compressible distal end 1450 of the applicator is first positioned on the skin surface of the subject. The subject then exerts a force on the applicator, e.g., in the distal direction, which causes the compressible distal end 1450 to stretch and flatten the portion of the skin surface below. In some embodiments, for example, compressible distal end 1450 can be constructed of an elastomeric material and biased in a radially inward direction. In other embodiments, compressible distal end 1450 may be biased in a radially outward direction. The force on the applicator can cause the edge portion of the compressible distal end 1450 that is in contact with the skin surface to displace in a radially outward direction, thereby generating a radially outward force on the portion of the skin surface below the applicator and causing the skin surface to stretch and flatten.

Further, according to some embodiments, applying a force on the applicator also causes the medical device, such as the sensor control unit, to advance from a first position within the applicator to a second position adjacent the skin surface. According to an aspect of some embodiments, the compressible distal end 1450 can be in an unloaded state (e.g., before a force is applied on the applicator) in the first position and in a loaded state (e.g., after a force is applied on the applicator) in the second position. Subsequently, the medical device is applied to the stretched and flat portion of the skin surface below the compressible distal end 1450. According to some embodiments, the application of the medical device may include placing the adhesive surface 105 of the sensor control unit 102 on the skin surface and/or positioning at least a portion of the analyte sensor below the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of a subject. In still other embodiments, application of the medical device may include placement of a drug-loaded patch on a skin surface. One skilled in the art will appreciate that the compressible distal end may be used with any of the aforementioned medical applications and is not meant to be limited to use in an applicator for analyte sensor insertion.

Exemplary embodiments of a sensor electronics Carrier

Fig. 9A is a proximal perspective view depicting an exemplary embodiment of a sensor electronics carrier 710, which sensor electronics carrier 710 may hold a sensor electronics within applicator 150. It may also hold a sharps carrier 1102 with a sharps module 2500. In this exemplary embodiment, sensor electronics carrier 710 has a generally hollow, circular, flat cylindrical shape and may include one or more deflectable sharp carrier locking arms 1524 (e.g., three), which locking arms 1524 extend proximally from a proximal surface around a centrally located spring alignment ridge 1516 for maintaining alignment of spring 1104. Each locking arm 1524 has a detent or retaining feature 1526 located at or near its proximal end. The anti-shock locks 1534 may be tabs located on the outer circumference of the outwardly extending sensor electronics carrier 710 and may lock the sensor electronics carrier 710 prior to ignition for added security. Rotation limiter 1506 may be a proximally extending relatively short protrusion on the proximal surface of sensor electronics carrier 710 that limits the rotation of carrier 710. As described below with reference to fig. 10 and 11, sharp carrier locking arms 1524 may interface with sharp carrier 1102.

Fig. 9B is a perspective view of the distal end of the sensor electronics carrier 710. Here, one or more sensor electronics retaining spring arms 1518 (e.g., three) are normally biased toward the position shown and include detents 1519 that, when received within recesses or cavities 1521, can pass over the distal surface of electronics housing 706 of device 102. In certain embodiments, after the sensor control device 102 has been adhered to the skin with the applicator 150, the user pulls the applicator 150 in a proximal direction (i.e., away from the skin). The adhesive force holds the sensor control device 102 to the skin and overcomes the lateral force exerted by the spring arm 1518. As a result, the spring arm 1518 deflects radially outward and disengages the detent 1519 from the sensor control 102, thereby releasing the sensor control 102 from the applicator 150.

Exemplary embodiments of the Sharp Carrier

Fig. 10 and 11 are a proximal perspective view and a side cross-sectional view, respectively, illustrating an exemplary embodiment of a sharp carrier 1102. The sharps support 1102 may grasp and hold the sharps module 2500 within the applicator 150. Near the distal end of sharp carrier 1102 may be an anti-rotation slot 1608, which when located in the central region of sharp carrier locking arm 1524 (as shown in fig. 9A) prevents sharp carrier 1102 from rotating. Anti-rotation slots 1608 may be located between portions of the sharp carrier base chamfer 1610, which may ensure that the sharp carrier 1102 is fully retracted through the sheath 704 when retracted at the end of the deployment process.

As shown in fig. 11, the sharpened retention arms 1618 may be located inside of the sharpened carrier 1102 about a central axis and may include sharpened retention clips 1620 at the distal end of each arm 1618. The sharpened retaining clip 1620 may have a proximal surface that may be nearly perpendicular to the central axis and may abut a distal-facing surface of the sharpened hub 2516 (fig. 17A).

Exemplary embodiments of sensor Module

Fig. 12A and 12B are top and bottom perspective views, respectively, depicting an exemplary embodiment of a sensor module 504. The module 504 may hold a connector 2300 (fig. 13A and 13B) and a sensor 104 (fig. 14). Module 504 can be securely coupled with electronics housing 706. One or more deflectable arms or module catches 2202 may snap into corresponding features 2010 of the housing 706. The sharpened slot 2208 may provide a location for the sharpened tip 2502 to pass through and the sharpened shaft 2504 to temporarily reside. The sensor flange 2212 can define a sensor position in a horizontal plane, prevent the sensor from lifting the connector 2300 off the post, and keep the sensor 104 parallel to the plane of the connector seal. It may also define the sensor bending geometry and the minimum bending radius. It can limit the travel of the sensor in the vertical direction and prevent the turret from protruding above the electronic housing surface and define the sensor tail length below the patch surface. The sensor wall 2216 may constrain the sensor and define a sensor bend geometry and a minimum bend radius.

Fig. 13A and 13B are perspective views depicting an exemplary embodiment of a connector 2300 in an open state and a closed state, respectively. Connector 2300 may be made of silicone rubber that encapsulates a flexible carbon-impregnated polymer module that serves as electrically conductive contacts 2302 between sensor 104 and circuit contacts of the electronics within housing 706. The connector may also serve as a moisture barrier for the sensor 104 when assembled in a compressed state after transfer from the container to the applicator and after application to the user's skin. The plurality of sealing surfaces 2304 may provide a water-tight seal for the electrical and sensor contacts. One or more hinges 2208 may connect two distal and proximal portions of the connector 2300.

Fig. 14 is a perspective view depicting an exemplary embodiment of the sensor 104. The neck 2406 may be an area that allows the sensor to fold (e.g., 90 degrees). The membrane on tail 2408 may cover the active analyte sensing elements of sensor 104. Tail 2408 may be the portion of sensor 104 that resides under the user's skin after insertion. Flag 2404 may include contacts and sealing surfaces. The biasing tower 2412 may be a tab that biases the tail 2408 into the sharp slot 2208. The offset fulcrum 2414 may be a branch of an offset tower 2412, the offset tower 2412 contacting the inner surface of the needle to offset the tail into the slot. The bias adjusters 2416 can reduce local bending of the tail connections and prevent sensor trace damage. Contacts 2418 may electrically couple the active portion of the sensor to connector 2300. Service loop 2420 can translate the electrical path 90 degrees from vertical and engage sensor flange 2212 (fig. 12B).

Fig. 15A and 15B are bottom and top perspective views, respectively, depicting an exemplary embodiment of a sensor module assembly including sensor module 504, connector 2300, and sensor 104. In accordance with one aspect of the foregoing embodiment, during or after insertion, the sensor 104 may experience an axial force that pushes the sensor 104 upward in the proximal direction and into the sensor module 105, as illustrated by force F1 in fig. 15A. According to some embodiments, this may result in a reverse force F2 being applied to the neck 2406 of the sensor 104, and thus a reverse force F3 being transferred to the service loop 2420 of the sensor 104. In some embodiments, for example, the axial force F1 may occur as a result of a sensor insertion mechanism, wherein the sensor is designed to push itself through tissue, a sharp retraction mechanism during insertion, or due to a physiological reaction of the tissue surrounding the sensor 104 (e.g., after insertion).

FIGS. 16A and 16B are partial close-up views of an exemplary embodiment of a sensor module assembly having certain axial reinforcement features. In a general sense, embodiments described herein are directed to mitigating the effects of axial forces on the sensor due to insertion and/or retraction mechanisms or due to physiological reactions to the sensor in vivo. As shown in fig. 16A and 16B, according to one aspect of this embodiment, the sensor 3104 includes a proximal portion having a hook feature 3106, the hook feature 3106 being configured to engage a capture feature 3506 of the sensor module 3504. In some embodiments, sensor module 3504 may also include a gap region 3508 to allow a distal portion of sensor 3104 to swing back during assembly to allow the hook feature 3106 of sensor 3104 to be assembled over capture feature 3506 of sensor module 3504 and into capture feature 3506 of sensor module 3504.

According to another aspect of the embodiments, the hook and catch features 3106, 3506 operate in the following manner. Sensor 3104 includes a proximal sensor portion coupled to sensor module 3504 as described above and a distal sensor portion located below the surface of the skin in contact with bodily fluids. As shown in fig. 16A and 16B, the proximal sensor portion includes a hook feature 3106 adjacent to a capture feature 3506 of a sensor module 3504. During or after sensor insertion, one or more forces are applied in a proximal direction along the longitudinal axis of the sensor 3104. In response to one or more forces, the hook feature 3106 engages the capture feature 3506 to prevent the sensor 3104 from being displaced in a proximal direction along the longitudinal axis.

According to another aspect of an embodiment, sensor 3104 may be assembled with sensor module 3504 in the following manner. The sensor 3104 is loaded into the sensor module 3504 by moving the proximal sensor portion in a lateral direction so that the hook feature 3106 is proximate to the capture feature 3506 of the sensor module 3504. More specifically, moving the proximal sensor portion in the lateral direction causes the proximal sensor portion to move into the gap region 3508 of the sensor module 3504.

Although fig. 16A and 16B depict the hook feature 3106 as part of the sensor 3104 and the capture feature 3506 as part of the sensor module 3504, those skilled in the art will appreciate that the hook feature 3106 may instead be part of the sensor module 3504 and, likewise, the capture feature 3506 may instead be part of the sensor 3106. Similarly, those skilled in the art will also recognize that other mechanisms implemented on sensor 3104 and sensor module 3504 to prevent axial displacement of sensor 3104 (e.g., detents, latches, fasteners, screws, etc.) are possible and within the scope of the present disclosure.

Exemplary embodiments of the Sharp Module

Fig. 17A is a perspective view depicting an exemplary embodiment of a sharps module 2500 prior to assembly within a sensor module 504 (fig. 6B). Sharp portion 2502 may include a distal tip 2506, and distal tip 2506 may penetrate the skin while carrying the sensor tail in the hollow or slot of sharp shaft 2504 to bring the active surface of the sensor tail into contact with bodily fluids. Hub pushing cylinder 2508 may provide a surface for the sharp carrier to push during insertion. Hub small cylinder 2512 may provide space for sharp hub contact surface 1622 (fig. 11) to extend. Hub pawl positioning cylinders 2514 can provide distally facing surfaces of hub pawls 2516 for abutment with sharp hub contact surfaces 1622. Hub pawls 2516 may include tapered surfaces that open clips 1620 during installation of the sharp module 2500. Further details regarding the implementation of the sharp modules, sharp portions, their components, and variations thereof are described in U.S. patent publication No. 2014/0171771, which is incorporated herein by reference in its entirety for all purposes.

Fig. 17B, 17C, and 17D depict exemplary embodiments of plastic sharp modules. By way of background, according to one aspect of an embodiment, a plastic sharp may be advantageous in at least two respects.

First, the plastic sharp may reduce trauma to tissue during the skin insertion process relative to a metal sharp. Due to their manufacturing processes, such as chemical etching and mechanical forming, sharp metal tips are typically characterized by sharp edges and burrs that can cause trauma to the tissue at the insertion site. In contrast, plastic sharps may be designed with rounded edges and a smooth finish to reduce trauma when the sharp is placed through tissue. Furthermore, those skilled in the art will appreciate that reducing trauma during the insertion process can result in reduced ESA and improved accuracy of analyte level readings shortly after insertion.

Second, the plastic sharp portions can simplify the applicator manufacturing and assembly process. As with the previously described embodiments, some applicators are provided to the user in two parts: (1) an applicator comprising a sharp portion and sensor electronics in a sensor control unit, and (2) a sensor receptacle. This requires the user to assemble the sensor into the sensor control unit. One reason for the two-piece assembly is to allow electron beam sterilization of the sensor to be performed separately from the applicator containing the metal sharp and sensor electronics. Metal sharps, such as those made of stainless steel, have a higher density relative to sharps made of polymeric or plastic materials. Thus, scattering of the electron beam from the impact of the electron beam on the sharp metal portion may damage the sensor electronics of the sensor control unit. By utilizing a plastic sharp (e.g., a sharp made of a polymeric material) and additional shielding features to distance the electron beam path from the sensor electronics, the applicator and sensor can be sterilized and packaged in a single package, thereby reducing manufacturing costs and simplifying the assembly process for the user.

Referring to fig. 17B, a perspective view of an exemplary embodiment of a plastic sharp module 2550 is shown and can include a hub 2562 coupled to a sharp proximal end, a sharp shaft 2554, a sharp distal tip 2556 configured to penetrate a skin surface, and a sensor channel 2558 configured to receive at least a portion of an analyte sensor 104. Any or all of the components of sharp module 2550 may be comprised of a plastic material, such as a thermoplastic material, a Liquid Crystal Polymer (LCP), or similar polymeric material. According to some embodiments, for example, the sharps module may comprise a polyetheretherketone material. In other embodiments, silicone or other lubricants may be applied to the outer surface of the sharp module and/or incorporated into the polymeric material of the sharp module to reduce trauma caused during the insertion process. Further, to reduce trauma during insertion, one or more of the sharp shaft 2554, the sharp distal tip 2556, or the alignment features 2568 (described below) can include a chamfer and/or a smooth edge.

According to some embodiments, when assembled, the distal end of the analyte sensor may be in a proximal position relative to the sharp distal tip 2556. In other embodiments, the distal end of the analyte sensor and the sharp distal tip 2556 are co-located.

According to another aspect of some embodiments, the plastic sharp module 2550 can further comprise an alignment feature 2568, the alignment feature 2568 configured to prevent rotational movement along a vertical axis 2545 of the sharp module 2550 during the insertion process, wherein the alignment feature 2568 can be positioned along a proximal portion of the sharp shaft 2554.

Fig. 17C and 17D are side and perspective views, respectively, depicting another exemplary embodiment of plastic sharp module 2570. Similar to the embodiment described with respect to fig. 17B, the plastic sharp module 2570 can include a hub 2562 coupled to a sharp proximal end, a sharp shaft 2554, a sharp distal tip 2556 configured to penetrate a skin surface, and a sensor channel 2558 configured to receive at least a portion of the analyte sensor 104. Any or all of the components of sharp module 2570 may be comprised of a plastic material, such as a thermoplastic, LCP, or similar polymeric material. In some embodiments, silicone or other lubricant may be applied to the outer surface of the sharp module 2570 and/or incorporated into the polymeric material of the sharp module 2570 to reduce trauma caused during the insertion process.

According to some embodiments, the sharpened shaft 2574 can include a distal portion 2577 terminating in a distal tip 2576, with at least a portion of the sensor channel 2578 disposed therein. The sharpened shaft 2574 can also have a proximal portion 2575 adjacent to the distal portion 2577, wherein the proximal portion 2575 is solid, partially solid, or hollow, and is coupled to the hub 2582. Although fig. 17C and 17D depict the sensor channel 2578 as being located only within the distal portion 2577, those skilled in the art will appreciate that the sensor channel 2578 could also extend through a majority of the sharpened shaft 2574 or along the entire length of the sharpened shaft 2574 (e.g., as shown in fig. 17B), including through at least a portion of the proximal portion 2575. Further, according to another aspect of some embodiments, at least a portion of the proximal portion 2575 can have a wall thickness that is greater than the wall thickness of the distal portion 2577 to reduce the likelihood of stress buckling of the sharp during the insertion process. According to another aspect of some embodiments, plastic sharp module 2570 may include one or more ribs (not shown) adjacent sharp hub portion 2582 to reduce compressive loads around hub portion 2582 and to mitigate stress buckling of the sharp during the insertion process.

Fig. 17E is a cross-sectional view depicting an exemplary embodiment of an applicator 150 having a plastic sharp module during an electron beam sterilization process. As shown by the rectangular area a, the electron beam is focused on the plastic sharp 2550 of the sensor 104 and applicator 150 during the sterilization process. According to some embodiments, the cap 708 has been secured to the applicator housing 702 to seal the sensor control device 102 within the applicator 150. During the sterilization process, electron beam scattering (as indicated by the diagonal arrows from plastic sharps 2550) in the direction and path of sensor electronics 160 has been reduced due to the use of plastic sharps 2550 instead of metal sharps. Although fig. 17E depicts a focused electron beam sterilization process, one skilled in the art will recognize that applicators with embodiments of plastic sharp modules may also be used during non-focused electron beam sterilization processes.

Fig. 17F is a flow chart depicting an exemplary embodiment method 1100 for disinfecting an applicator assembly according to the embodiments described above. In step 1105, the sensor control device 102 is loaded into the applicator 150. Sensor control device 102 may include various components, including an electronics housing, a printed circuit board located within the electronics housing and containing processing circuitry, an analyte sensor extending from a bottom portion of the electronics housing, and a plastic tip module having a plastic tip extending through the electronics housing. According to some embodiments, the plastic spike may also receive a portion of the analyte sensor extending from the bottom of the electronics housing. As previously described, at step 1110, the cap 708 is secured to the applicator housing 702 of the applicator 150, thereby sealing the sensor control device 102 within the applicator 150. At step 1115, the analyte sensor 104 and plastic sharps 2550 are sterilized with radiation while the sensor control device 102 is positioned within the applicator 150.

According to some embodiments, the sensor control device 102 may further comprise at least one shield located within the electronic housing, wherein the one or more shields are configured to shield the processing circuitry from radiation during the sterilization process. In some embodiments, the shield may include a magnet that generates a static magnetic field to divert radiation away from the processing circuitry. In this manner, the combination of the plastic sharp module and the magnetic shield/deflector can cooperate to protect the sensor electronics from radiation during the sterilization process.

Another exemplary embodiment of a sharp portion designed to reduce trauma during the sensor insertion and retraction process will now be described. More specifically, certain embodiments described herein are directed to a sharp portion comprising a metallic material (e.g., stainless steel) and manufactured by a casting process. According to one aspect of an embodiment, the cast sharp may be characterized as having a sharp tip, all other edges of which include rounded edges. As previously mentioned, metal sharp portions made by chemical etching and mechanical forming processes can result in sharp edges and unintended hook features. For example, fig. 17G is a photograph depicting a metal sharp 2502 fabricated by a chemical etching and mechanical forming process. As can be seen in fig. 17G, the metal sharp 2502 includes a sharp distal tip 2506 having a hook feature. These and other unintended transition features can result in increased trauma to the tissue during the sensor insertion and retraction process. In contrast, fig. 17H is a photograph depicting a cast sharp 2602, i.e., a metal sharp made by a casting process. As can be seen in fig. 17H, cast sharp 2602 further includes a sharp distal tip 2606. However, cast sharp 2602 includes only smooth, rounded edges without any unintended sharp edges or transitions.

As with the previously described sharp embodiments, the cast sharp 2602 embodiments described herein may also be assembled into a sharp module having a sharp portion and a hub portion. Also, the sharp portion includes a sharp shaft, a sharp proximal end coupled to the distal end of the hub portion, and a sharp distal tip configured to penetrate the skin surface. According to an aspect of an embodiment, one or all of the sharp portion, sharp shaft, and/or sharp distal tip of cast sharp 2602 may include one or more rounded edges.

Further, one skilled in the art will appreciate that the cast sharp 2602 embodiments described herein may be similarly used with any sensor described herein, including in vivo analyte sensors configured to measure analyte levels in a bodily fluid of a subject. For example, in some embodiments, cast prong 2602 can include a sensor channel (not shown) configured to receive at least a portion of an analyte sensor. Similarly, in some embodiments of a sharpened module assembly utilizing cast sharpened portion 2602, the distal end of the analyte sensor may be in a proximal position relative to sharpened distal tip 2606. In other embodiments, the distal end of the analyte sensor and the sharp distal tip 2606 are co-located.

Other exemplary embodiments of a sharp designed to reduce trauma during the sensor insertion process will now be described. Referring back to fig. 17A, an exemplary embodiment of a sharps module 2500 (shown without an analyte sensor) is shown and includes a sharps 2502, the sharps 2502 including a sensor channel having a U-shaped geometry configured to receive at least a portion of an analyte sensor and a distal tip 2506, the distal tip 2506 configured to penetrate a skin surface during a sensor insertion process.

In some embodiments, the sharp module may include a sharp having a distal tip with an offset geometry configured to form a smaller opening in the skin relative to other sharps (e.g., sharp 2502 depicted in fig. 17A). Turning to fig. 17I, a perspective view of an exemplary embodiment of a sharpened module 2620 (with analyte sensor 104) with an offset tip portion is shown. Similar to the sharp module previously described, the sharp module 2620 may include a sharp shaft 2624 coupled to the hub 2632 at a proximal end, a sensor channel 2628 configured to receive at least a portion of the analyte sensor 104, and a distal tip 2626 configured to penetrate the skin surface during the sensor insertion process.

According to one aspect of an embodiment, one or more side walls 2629 forming the sensor channel 2628 are disposed along the sharpened axis 2624 at a predetermined distance Dsc from the distal tip 2626. In certain embodiments, the predetermined distance Dsc may be between 1 millimeter and 8 millimeters. In other embodiments, the predetermined distance Dsc may be between 2 millimeters and 5 millimeters. Those skilled in the art will recognize that other predetermined distances Dsc may be utilized and are well within the scope of the present disclosure. In other words, according to some embodiments, the sensor channel 2628 is in a spaced relationship with the distal tip 2626. In this regard, the distal tip 2626 has a reduced cross-sectional footprint relative to, for example, the distal tip 2506 of the sharps module 2500 with the sensor channel of the sharps module 2500 adjacent the distal tip 2506. According to another aspect of an embodiment, at the end of the distal tip 2626 is an offset tip portion 2627, the offset tip portion 2627 configured to prevent the sensor tip 2408 from being damaged during insertion and creating a small opening in the skin. In some embodiments, the offset tip portion 2627 may be a separate element coupled to the distal end of the sharpened shaft 2624. In other embodiments, the offset tip portion 2627 may be formed by the distal tip 2506 or a portion of the sharpened shaft 2624. During insertion, as the sharp moves into the skin surface, the offset tip portion 2627 may cause the skin surrounding the skin opening to stretch and widen in a lateral direction without further cutting of the skin tissue. In this regard, the trauma during the sensor insertion process is less.

Referring next to fig. 17J, a perspective view of another exemplary embodiment of a sharp module 2640 (with analyte sensor 104) with an offset tip portion is shown. Similar to the previous embodiments, the sharp module 2640 may include a sharp shaft 2644 coupled to the hub 2652 at a proximal end, a sensor channel 2648 configured to receive at least a portion of the analyte sensor 104, and a distal tip 2646 configured to penetrate the skin surface during the sensor insertion process. In accordance with one aspect of an embodiment, the sensor channel 2648 can include a first sidewall 2649a and a second sidewall 2649b, wherein the first sidewall 2649a extends to the distal tip 2646, wherein a distal end of the first sidewall 2649a forms an offset tip portion 2647, and wherein the second sidewall 2649b is disposed along the sharp axis 2644 at a predetermined distance from the distal tip 2646, and wherein a distal end of the second sidewall 2649b is proximate to the distal end of the first sidewall 2649 a. Those skilled in the art will appreciate that in other embodiments, second sidewall 2649b may extend to distal tip 2646 to form offset tip portion 2647 instead of first sidewall 2649 a. Moreover, offset tip portion 2647 may be formed from a third or fourth sidewall (not shown), and such geometries are well within the scope of the present disclosure.

With respect to the sharp and pointed module embodiments described herein, one skilled in the art will recognize that any or all of the components may comprise a metallic material (e.g., stainless steel) or a plastic material (e.g., a liquid crystal polymer). Further, one skilled in the art will appreciate that any of the sharps and/or sharps module embodiments described herein may be used or combined with any of the sensors, sensor modules, sensor electronics carriers, sheaths, applicator devices, or any other analyte monitoring system components described herein.

Exemplary embodiments of the motorized applicator

Fig. 18A and 18B are cross-sectional and exploded views, respectively, depicting an exemplary embodiment of a motorized applicator 4150 for inserting an analyte sensor into a subject. According to one aspect of an embodiment, the housing 4702 of the motorized applicator 4150 operates as a trigger that releases and activates the drive spring 4606 under light pressure to push the sensor electronics carrier 4710 downward and insert the sharp and analyte sensors into the subject. When the subject pulls the applicator 4150 away from the skin, the retraction spring 4604 is triggered, causing the sharp to exit from the subject. According to an aspect of an embodiment, the powered applicator 4150 may provide a higher, more controlled insertion speed relative to applicators that rely on manual force for insertion. A further advantage of the powered applicator 4150 over applicators that rely on manual force for insertion is that the powered applicator 4150 may improve insertion success and may also reduce trauma at the insertion site.

With reference to fig. 18A and 18B, various components of the motorized applicator 4150 will now be described. As shown in fig. 18A, as a cross-sectional view of the assembled motorized applicator 4150 (in an initial state), and an exploded view as shown in fig. 18B, the motorized applicator 4150 may include the following components: housing 4702, sharp carrier 4602, retraction spring 4604, sheath 4704, striker 4705, drive spring 4606, sensor electronics carrier 4710. Further, although not shown, the motorized applicator 4150 may also include any of the embodiments of the sensor control unit, analyte sensor, and sharps described herein or in other publications incorporated by reference.

Fig. 19A-19L are various views illustrating an exemplary embodiment of a motorized applicator 4150 during various stages of deployment.

Fig. 19A is a cross-sectional view showing the motorized applicator 4150 in an initial state, in which the distal end of the applicator 4150 is ready for placement on a skin surface of a subject. In an initial state, both the drive spring 4606 and the retraction spring 4604 are in a preloaded state. Drive spring 4606 includes a first end coupled to striker 4705 and a second end coupled to sensor electronics carrier 4710. Retraction spring 4604 includes a first end coupled to sharp carrier 4602 and a second end coupled to sensor electronics carrier 4710. As best seen in fig. 19A, in an initial state, the sensor electronics carrier 4710 and the sharp carrier 4602 are in a first position within the applicator 4150 in spaced relation to the skin surface.

In accordance with an aspect of an embodiment, in an initial state, the sensor electronics carrier 4710 is coupled to the sheath 4704 by one or more latch tab structures. Fig. 19B depicts a perspective view of the sheath 4704 including one or more sheath tabs 4706. Fig. 19C depicts a perspective view of the sensor electronics carrier 4710, the sensor electronics carrier 4710 including one or more corresponding sensor electronics carrier latches 4603. As best seen in fig. 19A, in an initial state, each of the one or more sensor electronics carrier latches 4603 engage with a respective sheath latch 4706. Although fig. 19B and 19C depict three sheathing tabs 4706 and three sensor electronics carrier latches 4603, those skilled in the art will appreciate that fewer or more latch tab structures may be used and those embodiments are well within the scope of the present disclosure.

Fig. 19D is a cross-sectional view showing the motorized applicator 4150 in a fired state, wherein a force F1 is applied to the applicator 4150 in a distal direction (as indicated by the black arrows). In accordance with one aspect of an embodiment, application of force F1 causes the striker 4705 to move in a distal direction along the sheath 4704 and subsequently disengage the sheath tab 4706 from the sensor electronics carrier latch 4603 (as indicated by the white arrow). Disengagement of the sheath tab 4706 from the sensor electronics carrier latch 4603 causes the drive spring 4606 to expand in a distal direction, thereby "firing" the applicator 4150. As the drive spring 4606 expands in the distal direction, the sensor electronics carrier 4710 and the sharpened carrier 4602 also move in the distal direction to a second position adjacent to the skin surface.

According to some embodiments, applying force F1 may increase the load on the drive spring 4606 by further compressing the drive spring 4606 before disengaging the sheath tab 4706.

According to one aspect of an embodiment, the "cylinder-to-cylinder" design of the sheath 4704 and striker 4705 can provide stable and simultaneous release of all three sensor electronics carrier latches 4603. Furthermore, in some embodiments, certain features may provide enhanced stability when the sensor electronics carrier 4710 and the pointed carrier 4602 are displaced from a first position to a second position. For example, as shown in fig. 19E, the sensor electronics carrier 4710 can include one or more sensor electronics carrier tabs 4605, the sensor electronics carrier tabs 4605 being configured to travel in a distal direction along one or more sheath rails 4707 of the sheath 4704. Further, as shown in fig. 19F, according to some embodiments, the sensor electronics carrier 4710 can include one or more sensor electronics carrier buffers 4607, each sensor electronics carrier buffer 4607 can be biased against an inner surface of the sheath 4704 as the sensor electronics carrier 4710 and the sharpened carrier 4602 are displaced from the first position to the second position.

Fig. 19G is a cross-sectional view showing the motorized applicator 4150 in an inserted state, with force F1 still being applied to the applicator 4150 in the distal direction (as indicated by the black arrow). Force F1 may be the subject pushing and holding applicator 4150 against the skin during the insertion process. During the insertion state, the sharp and a portion of the analyte sensor (not shown) are located below the skin surface and in contact with the body fluid of the subject. Also, at this stage, the sharp retraction process has not yet begun. As best seen in fig. 19I, the sensor electronics carrier locking arms 4524 continue to be restrained by the sheaths 4704, thereby preventing retraction of the sharpened carrier 4602 (and the sharpened portion).

According to another aspect of the embodiment, during the insertion state, when the sensor electronics carrier 4710 reaches the second position, the sensor electronics carrier 4710 and a distal portion of a sensor control unit (not shown) coupled with the sensor electronics carrier 4710 remain in contact with the skin surface. In some embodiments, the distal portion of the sensor control unit may be an adhesive surface.

Further, according to some embodiments, as best seen in fig. 19H, during the insertion state, the sensor electronics carrier tab 4605 located within the sheath track 4707 travels in the distal direction to the second position, but still is located above the bottom of the applicator 4150, as shown by distance R.

Fig. 19J is a cross-sectional view showing the powered applicator 4150 in a retracted-sharps state. According to one aspect of an embodiment, after the insertion state is complete, the subject applies force F2 to applicator 4150, this time in the proximal direction. Force F2 may be the subject pulling applicator 4150 away or moving it away from the skin surface. Application of force F2 causes retraction spring 4604 to move sharp carrier 4602 from the second position (e.g., adjacent the skin surface) to a third position within applicator 4150, which causes the sharp to withdraw from the skin surface.

More specifically, when force F2 is applied, drive spring 4606 displaces sensor electronics carrier 4710 to the bottom of applicator 4150. As shown in fig. 19J, a portion of the sensor electronics carrier 4710 protrudes below the bottom of the sheath 4704. Similarly, as shown in fig. 19K, during the sharps retracted state, the sensor electronics carrier tabs 4605 are flush with the bottom of the sheath slots 4707.

As best seen in fig. 19L, according to another aspect of an embodiment, as force F2 continues to be applied, each of the sensor electronics carrier locking arms 4524 are positioned into the sheath notches 4708. Thus, the sensor electronics carrier locking arms 4524 biased in the radially outward direction may expand in the radially outward direction through the sheath recesses 4708. In turn, the sensor electronics carrier locking arms 4524 disengage and release from the sharp carrier 4602, and the retraction spring 4604 is free to expand in the proximal direction. When the retraction spring 4604 expands in the proximal direction, the sharp carrier 4602 is displaced to a third position within the applicator 4150 (e.g., the top of the sheath 4704), which causes the sharp to withdraw from the skin surface.

With respect to the drive spring 4606 and the spike retract spring 4604, it should be noted that although compression springs are shown in fig. 18A-18B and 19A-19L, those skilled in the art will appreciate that other types of springs may be used in any of the embodiments described herein, including but not limited to torsion springs, belleville springs, plate springs, and others. Further, those skilled in the art will appreciate that the insertion and retraction speeds of the applicator embodiments described herein can be varied by varying the stiffness or length of the drive spring and retraction spring, respectively. Similarly, one skilled in the art will appreciate that the time of the sharp retraction may be modified by modifying the depth of the sheath channel (e.g., increasing the depth of the sheath channel may result in earlier sharp retraction).

With respect to any of the applicator embodiments described herein and any components thereof, including but not limited to the sharp, pointed module, and sensor module embodiments, one skilled in the art will appreciate that the embodiments may be sized and configured for use with a sensor configured to sense analyte levels in bodily fluids in the epidermis, dermis, or subcutaneous tissue of a subject. In some embodiments, for example, both the sharp and distal portions of the analyte sensors disclosed herein can be sized and configured to be positioned at a particular tip depth (i.e., the furthest penetration point in a tissue or layer of the subject's body, such as in the epidermis, dermis, or subcutaneous tissue). With respect to some applicator embodiments, one skilled in the art will appreciate that certain embodiments of the sharp portion may be sized and configured to be positioned at different tip depths in the subject's body relative to the final tip depth of the analyte sensor. In some embodiments, for example, the sharp may be positioned at a first end depth in the epidermis of the subject prior to retraction, while the distal portion of the analyte sensor may be positioned at a second end depth in the dermis of the subject. In other embodiments, the sharp may be positioned at a first end depth in the subject's dermis prior to retraction, while the distal portion of the analyte sensor may be positioned at a second end depth in the subject's subcutaneous tissue. In still other embodiments, the sharp may be positioned at a first tip depth prior to retraction and the analyte sensor may be positioned at a second tip depth, wherein both the first tip depth and the second tip depth are in the same layer or tissue of the subject's body.

Further, with respect to any of the applicator embodiments described herein, including but not limited to the motorized applicators of fig. 18A, 18B, and 19A-19L, one skilled in the art will appreciate that the analyte sensor and one or more structural components coupled thereto, including but not limited to one or more spring mechanisms, may be arranged within the applicator in an off-center position relative to one or more axes of the applicator. In some applicator embodiments, for example, the analyte sensor and the spring mechanism may be disposed at a first off-center position relative to the axis of the applicator on a first side of the applicator, and the sensor electronics may be disposed at a second off-center position relative to the axis of the applicator on a second side of the applicator. In other applicator embodiments, the analyte sensor, spring mechanism, and sensor electronics may be disposed in an off-center position on the same side relative to the axis of the applicator. Those skilled in the art will appreciate that other arrangements and configurations in which any or all of the analyte sensor, spring mechanism, sensor electronics, and other components of the applicator are disposed in a centered or off-center position relative to one or more axes of the applicator are possible and well within the scope of the present disclosure.

A number of deflectable structures are described herein, including but not limited to deflectable pawl catch 1402, deflectable locking arm 1412, sharp carrier locking arm 1524, sharp retention arm 1618, and module catch 2202. These deflectable structures are composed of a resilient material such as plastic or metal (or other) and operate in a manner well known to those of ordinary skill in the art. Each deflectable structure has a rest state or position biased by a resilient material. If the applied force causes the structure to deflect or move from the rest state or position, the bias of the resilient material will cause the structure to return to the rest state or position once the force is removed (or reduced). In many cases, these structures are configured as arms with detents or snaps, but other structures or configurations may be used that maintain the same characteristics of the deflectable and return to the rest position, including but not limited to legs, clips, snaps, abutments on deflectable members, and the like.

Exemplary embodiments of an applicator and sensor control device for a one-piece architecture

As previously mentioned, certain embodiments of the sensor control apparatus 102 and applicator 150 may be provided to the user in multiple packages. For example, some embodiments, such as those described with respect to fig. 3A-3G, may include a "two-piece" architecture that requires final assembly by the user before the sensor can be properly delivered to the target monitoring location. More specifically, the sensors and associated electrical components included in the sensor control device are provided to the user in a plurality (e.g., two) of packages, each of which may or may not be sealed with a sterile barrier, but at least enclosed within a package. The user must open the package and manually assemble the components as specified, and then transfer the sensor with the applicator to the target monitoring location. For example, referring again to fig. 3A-3G, the sensor tray and applicator are provided to the user as separate packages, thus requiring the user to open each package and finally assemble the system. In some applications, the separate sealed packages allow the tray and applicator to be sterilized during a separate sterilization process that is unique to the contents of each package, otherwise incompatible with the contents of another package.

More specifically, a tray including a plug assembly (including a sensor and a sharp portion) may be sterilized using radiation sterilization, such as electron beam (or "E-beam") radiation. However, radiation sterilization can damage electrical components disposed within the housing of the sensor control device. Thus, if it is desired to sterilize the applicator of the housing containing the sensor control device, it may be sterilized via another method, such as gas chemical sterilization using ethylene oxide. However, chemical sterilization of the gas can destroy enzymes or other chemicals and organisms contained on the sensor. Due to this sterilization incompatibility, the tray and applicator can be sterilized in separate sterilization processes and then packaged separately, requiring the user to finally assemble the components upon receipt.

According to other embodiments of the present disclosure, a sensor control device (e.g., an analyte sensor device) may include a one-piece architecture that incorporates sterilization techniques specifically designed for the one-piece architecture. The one-piece architecture allows the sensor control device assembly to be delivered to the user in a single sealed package without any end-user assembly steps. Instead, the user need only open one package and then deliver the sensor control device to the target monitoring location. The one-piece system architecture described herein may prove advantageous in eliminating components, various manufacturing process steps, and user assembly steps. Thus, packaging and waste are reduced, and the likelihood of a user making mistakes or contaminating the system is mitigated.

According to some embodiments, a Sensor Subassembly (SSA) may be constructed and sterilized. The sterilization may be, for example, radiation, such as electron beam (E-beam radiation), but other sterilization methods may alternatively be used, including but not limited to gamma radiation, X-ray radiation, or any combination thereof. Embodiments of methods of making analyte monitoring systems using the SSA are now described, as well as embodiments of sensor control devices having the SSA and applicators used therewith. SSA may be manufactured and then sterilized. During sterilization, the SSA may include both the analyte sensor and the insertion spike. The sterilized SSA can then be assembled to form (e.g., assemble) a sensor control device, e.g., the sterilized SSA can be placed such that the sensor is in electrical contact with any electronics in the sensor electronics carrier. The sensor control device can then be assembled to form (e.g., as a one-piece assembly) an applicator (e.g., as a single-piece component), wherein the applicator (also referred to as an analyte sensor inserter) is configured to apply the sensor control device to the body of a user. The one-piece assembly can be packaged and/or distributed (e.g., shipped) to a user or healthcare professional.

Fig. 20A-20G depict a first embodiment of an applicator for use with a sensor control device having an SSA. Fig. 21A-21G depict a second embodiment of an applicator for use with a sensor control device having an SSA.

Fig. 22A-22G depict a first embodiment of a sensor control device having SSA but no adhesive patch. Fig. 23A-23G depict a second embodiment of a sensor control device having an SSA and an adhesive patch.

Fig. 24A-24G depict a third embodiment of a sensor control device having an SSA and a bottom surface slot, but no adhesive patch. Fig. 25A-25G depict a fourth embodiment of a sensor control device having an SSA, a bottom surface slot, and an adhesive patch.

Fig. 26A-26G depict a fifth embodiment of a sensor control device with SSA but without an adhesive patch. Fig. 27A-27G depict a sixth embodiment of a sensor control device having an SSA and an adhesive patch.

Fig. 28A-28G depict a seventh embodiment of a sensor control device having an SSA and a bottom surface slot, but no adhesive patch. Fig. 29A-29G depict an eighth embodiment of a sensor control device having an SSA, a bottom surface slot, and an adhesive patch.

According to other embodiments, the sensor control device, including the battery and sensor, may be installed in the applicator as a single piece assembly and sterilized using Focused Electron Beam (FEB). Other sterilization methods may alternatively be used, including but not limited to gamma radiation, X-ray radiation, or any combination thereof. Embodiments of methods of manufacturing analyte monitoring systems and using, for example, FEB sterilization, and embodiments of sensor control devices and applicators for use therewith, will now be described. The sensor control device including the sensor and the sharp portion may be manufactured or assembled, e.g. the sensor may be placed in electrical contact with any electronics in a sensor electronics carrier of the sensor control device. The sensor control device can then be assembled to form (e.g., as a one-piece assembly) an applicator, wherein the applicator is configured to apply the sensor control device to the body of the user. The assembled applicator with the sensor control device therein can then be sterilized with, for example, a FEB. The sterilized applicator can then be packaged and/or dispensed (e.g., shipped) to a user or health care professional. In some embodiments, the desiccant and foil seal may be added to the sterilized single-piece assembly prior to packaging.

Fig. 30A-30G depict a first embodiment of an applicator that is sterilized using, for example, FEB. Fig. 31A-31G depict a second embodiment of an applicator that is sterilized using, for example, FEB.

Fig. 32A-32G depict a first embodiment of a sensor control device that is sterilized using, for example, an FEB, and without an adhesive patch. Fig. 33A-33G depict a second embodiment of a sensor control device sterilized using, for example, an FEB, and having an adhesive patch.

Fig. 34A-34G depict a third embodiment of a sensor control device having a bottom surface slot and sterilized using, for example, an FEB, but without an adhesive patch. Fig. 35A-35G depict a fourth embodiment of a sensor control device having a bottom surface slot and sterilized using, for example, FEB, and having an adhesive patch.

For all of the embodiments shown and described in fig. 20A-35G, the solid lines may instead be depicted as dashed lines, which do not form part of the design. For all of the embodiments of the sensor control devices depicted in fig. 22A-29G and 32A-35G, the adhesive patch may alternatively be shown in dashed lines if shown in solid lines, and may be shown in dashed or solid lines if not shown.

Various aspects of the present subject matter are set forth below to review and/or supplement the embodiments so far described, with emphasis here being placed on the interrelationship and interchangeability of the following embodiments. In other words, emphasis is placed upon the fact that each feature of the embodiments can be combined with each and every other feature unless explicitly stated otherwise or logically infeasible.

In many exemplary embodiments, there is provided a method of applying a medical device to a subject using an applicator, the method comprising: positioning a distal end of the applicator on a skin surface of a subject, wherein at least a portion of the distal end comprises a compressible material; applying a force on the applicator to advance the medical device from a first position within the applicator to a second position adjacent the skin surface and cause the distal end of the applicator to stretch and flatten a portion of the skin surface adjacent the applicator; and applying the medical device to the stretched and flattened portion of the skin surface.

In these method embodiments, applying a force on the applicator may further comprise moving at least a compressible portion of the distal end of the applicator in a radially outward direction. Moving at least the compressible portion of the distal end of the applicator may further comprise generating a radially outward force on a portion of the skin surface adjacent the applicator.

In these method embodiments, applying the medical device to the stretched and flattened portion of the skin surface may further comprise placing an adhesive surface on the skin surface.

In these method embodiments, applying the medical device to the stretched and flattened portion of the skin surface may further comprise positioning at least a portion of the analyte sensor below the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of a subject.

In these method embodiments, at least the compressible portion of the distal end of the applicator may be biased in a radially inward direction. Alternatively, in these method embodiments, at least the compressible portion of the distal end of the applicator may be biased in a radially outward direction.

In these method embodiments, the at least compressible portion of the distal end may be in an unloaded state in the first position and the at least compressible portion of the distal end may be in a loaded state in the second position.

In these method embodiments, at least the compressible portion of the distal end of the applicator may comprise one or more of an elastomeric material, a metal, a plastic, or a composite leg or spring, or a combination thereof.

In these method embodiments, the cross-section of at least the compressible portion of the distal end of the applicator may comprise a continuous loop or a non-continuous shape.

In these method embodiments, the distal end of the applicator may be configured to detach from the applicator.

In many exemplary embodiments, there is provided an apparatus comprising: a medical device; and an applicator comprising a distal end configured to be positioned on a skin surface of a subject, wherein at least a portion of the distal end comprises a compressible material, wherein, in response to application of a force to the applicator: the medical device may be configured to be advanced from a first position within the applicator to a second position adjacent the skin, the distal end of the applicator may be configured to stretch and flatten a portion of the skin surface adjacent the applicator, and the medical device may be further configured to be applied to said stretched and flattened portion of said skin surface.

In these device embodiments, the at least compressible portion of the distal end of the applicator may be configured to move in a radially outward direction in response to application of a force to the applicator. The at least compressible portion of the distal end of the applicator may be further configured to generate a radially outward force on a portion of the skin surface adjacent the applicator.

In these apparatus embodiments, the medical device may include an adhesive surface that may be configured to interface with a skin surface.

In these apparatus embodiments, the medical device may include an analyte sensor, at least a portion of which may be configured to be located below the skin surface. The analyte sensor may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of a subject.

In these device embodiments, at least the compressible portion of the distal end of the applicator may be biased in a radially inward direction. Alternatively, in these method embodiments, at least the compressible portion of the distal end of the applicator may be biased in a radially outward direction.

In these device embodiments, the at least compressible portion of the distal end may be in an unloaded state in the first position, and wherein the at least compressible portion of the distal end may be in a loaded state in the second position.

In these device embodiments, at least the compressible portion of the distal end of the applicator may comprise one or more of an elastomeric material, metal, plastic, or composite legs or springs, or a combination thereof.

In these device embodiments, the cross-section of at least the compressible portion of the distal end of the applicator may comprise a continuous loop or a non-continuous shape.

In these device embodiments, the distal end of the applicator can be configured to detach from the applicator.

In many embodiments, there is provided an assembly for an applicator, the assembly comprising: a sharp module comprising a sharp portion and a hub portion, wherein the sharp portion may comprise a sharp shaft, a sharp proximal end coupled to a distal end of the hub portion, and a sharp distal tip configured to penetrate a skin surface of a subject, wherein the sharp module may further comprise a plastic material.

In these assembly embodiments, the sharp shaft may include one or more chamfered edges.

In these assembly embodiments, the sharp module may further comprise a thermoplastic material.

In these assembly embodiments, the sharps module may further comprise a polyetheretherketone material.

In these assembly embodiments, the sharp shaft may include an alignment flange configured to prevent rotational movement along the vertical axis of the sharp module during the insertion process. The alignment flange may be positioned along a proximal portion of the sharp shaft.

In these assembly embodiments, the assembly may further comprise an analyte sensor, wherein the analyte sensor may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject. The distal end of the analyte sensor may be in a proximal position relative to the sharp distal tip. The distal end of the analyte sensor and the sharp distal tip may be co-located. At least a portion of the analyte sensor may be positioned within the sensor channel of the sharpened shaft.

In these assembly embodiments, the sharp module may further comprise a liquid crystal polymeric material.

In these assembly embodiments, the assembly may further comprise a lubricant disposed on the outer surface of the sharp module.

In these assembly embodiments, the plastic material may include a lubricant.

In these assembly embodiments, the assembly may further comprise a sensor channel, wherein at least a portion of the sensor channel may be disposed in the distal portion of the sharpened shaft. The sensor channel may extend from a proximal portion of the sharpened shaft to a distal portion of the sharpened shaft. The sensor channel may be configured such that it does not extend beyond the distal portion of the sharpened shaft. The proximal portion of the sharp shaft may be hollow. The proximal portion of the sharp shaft may be solid. The wall thickness of at least a portion of the proximal portion of the sharp shaft may be greater than the wall thickness of the distal portion of the sharp shaft.

In these assembly embodiments, the assembly may further include one or more rib structures adjacent to the hub portion, wherein the one or more rib structures may be configured to reduce compressive loads around the hub portion.

In many embodiments, a method of making an analyte monitoring system is provided, the method comprising: loading a sensor control device into a sensor applicator, the sensor control device comprising: an electronic housing; a printed circuit board located within the electronics housing and including processing circuitry; an analyte sensor extending from a bottom of the electronics housing; and a sharps module comprising a plastic material and removably coupled to the electronics housing, wherein the sharps module comprises a sharp, and wherein the sharp extends through the electronics housing and receives a portion of the analyte sensor extending from a bottom of the electronics housing; securing a cap to the sensor applicator, thereby providing a barrier that seals the sensor control device within the sensor applicator; and sterilizing the analyte sensor and the sharp with radiation while the sensor control device can be positioned within the sensor applicator.

In these method embodiments, the sensor control device may further comprise at least one shield located within the electronic housing, and wherein the method may further comprise shielding the processing circuitry from radiation during sterilization with the at least one shield. The at least one shield may include a magnet, and wherein shielding the processing circuitry with the at least one shield may include: generating a static magnetic field by using a magnet; and transferring the radiation away from the processing circuitry using static magnetism. Sterilizing the analyte sensor and the sharp with radiation may further include sterilizing the analyte sensor and the sharp using an unfocused electron beam.

In these method embodiments, the analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in a bodily fluid located within the subject.

In these method embodiments, the sharp module may further comprise a thermoplastic material.

In these method embodiments, the sharp module may further comprise a polyetheretherketone material.

In these method embodiments, sterilizing the analyte sensor and the sharps may further comprise focusing an electron beam on the analyte sensor and the sharps.

In many embodiments, there is provided an assembly for an applicator, the assembly comprising: a sharp module comprising a sharp portion and a hub portion, wherein the sharp portion may comprise a sharp shaft, a sharp proximal end coupled to a distal end of the hub portion, and a sharp distal tip configured to penetrate a skin surface of a subject, wherein the sharp portion may further comprise a metallic material and may be formed by a casting process.

In these assembly embodiments, the sharp portion may further comprise a stainless steel material.

In these assembly embodiments, the sharp portion does not include a sharp edge.

In these assembly embodiments, the sharp portion may include one or more rounded edges.

In these assembly embodiments, the sharp shaft may include one or more rounded edges.

In these assembly embodiments, the sharp shaft and the sharp distal tip may include one or more rounded edges.

In these assembly embodiments, the assembly may further comprise an analyte sensor, wherein the analyte sensor may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject. The distal end of the analyte sensor may be in a proximal position relative to the sharp distal tip. The distal end of the analyte sensor and the sharp distal tip may be co-located. At least a portion of the analyte sensor may be positioned within the sensor channel of the sharpened shaft.

In many embodiments, a method of maintaining structural integrity of a sensor control unit comprising an analyte sensor and a sensor module is provided, the method comprising: positioning a distal sensor portion of the analyte sensor below a skin surface and in contact with a bodily fluid, wherein the analyte sensor comprises a proximal sensor portion coupled to a sensor module, and wherein the proximal sensor portion comprises a hook feature adjacent to a capture feature of the sensor module; receiving one or more forces in a proximal direction along a longitudinal axis of the analyte sensor; and engaging the hook feature with the capture feature and preventing displacement of the analyte sensor in a proximal direction along the longitudinal axis.

In these method embodiments, the method may further comprise loading the analyte sensor into the sensor module by moving the proximal sensor portion in a lateral direction to bring the hook feature into proximity with the capture feature of the sensor module. Moving the proximal sensor section in the lateral direction may comprise moving the proximal sensor section into a gap region of the sensor module.

In these method embodiments, the one or more forces may be generated by a sharp retraction process.

In these method embodiments, one or more forces may be generated by a physiological response to the analyte sensor.

In these method embodiments, the analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in a bodily fluid of the subject.

In many embodiments, a sensor control unit is provided, the sensor control unit comprising: a sensor module including a capture feature; an analyte sensor comprising a distal sensor portion and a proximal sensor portion, wherein the distal sensor portion can be configured to be positioned below a skin surface and in contact with a bodily fluid, and wherein the proximal sensor portion can be coupled to the sensor module and can include a hook feature adjacent to the capture feature, wherein the hook feature can be configured to engage the capture feature and prevent displacement of the analyte sensor caused by one or more forces received by the analyte sensor and in a proximal direction along a longitudinal axis of the analyte sensor.

In these sensor control unit embodiments, the sensor module may be configured to receive the analyte sensor by moving the proximal sensor portion in a lateral direction and bringing the hook feature into proximity with the capture feature of the sensor module. The sensor module may further comprise a gap region configured to receive the proximal sensor portion when the proximal sensor portion is movable in the lateral direction.

In these sensor control unit embodiments, one or more forces may be generated by the sharp retraction process.

In these sensor control unit embodiments, one or more forces may be generated by a physiological reaction to the analyte sensor.

In these sensor control unit embodiments, the analyte sensor may be an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject.

In many embodiments, a method of inserting an analyte sensor into a subject using an applicator is provided, the method comprising: positioning a distal end of an applicator on a skin surface, wherein the applicator can include a drive spring, a retraction spring, a sensor electronics carrier, a sharp carrier, and an analyte sensor; applying a first force to the applicator to cause the drive spring to move the sensor electronics carrier and the sharp carrier from a first position within the applicator spaced from the skin surface to a second position adjacent the skin surface and position the sharp portion of the sharp carrier and a portion of the analyte sensor below the skin surface and in contact with the bodily fluid of the subject; and applying a second force to the applicator to cause the retraction spring to move the sharp carrier from the second position to a third position within the applicator and withdraw the sharp from the skin surface.

In these method embodiments, applying the first force may include applying a force in a distal direction, and wherein applying the second force may include applying a force in a proximal direction.

In these method embodiments, the applicator may further comprise a striker and a sheath, and wherein applying the first force to the applicator further causes the striker to disengage the one or more sheath tabs of the sheath from the one or more sensor electronics carrier latches of the sensor electronics carrier and causes the drive spring to expand. The drive spring may be in a preloaded state prior to application of the first force, and wherein disengaging the one or more sheath tabs causes the drive spring to expand in a distal direction. Applying a first force to the applicator increases the load on the drive spring before disengaging the striker from the one or more shield tabs. The drive spring may be in a preloaded state prior to application of the first force, and wherein the drive spring may include a first end coupled to the striker and a second end coupled to the sensor electronics carrier.

In these method embodiments, the applicator may further comprise a sensor control unit coupled to the sensor electronics carrier, and wherein a distal portion of the sensor control unit may be in contact with the skin surface at the second location. Moving the sensor electronics carrier and the sharps carrier from the first position to the second position may include one or more sensor electronics carrier tabs of the sensor electronics carrier traveling in a distal direction along one or more sheath rails of the sheath. One or more sensor electronics carrier bumpers of the sensor electronics carrier may be biased against the inner surface of the sheath while the sensor electronics carrier and the sharpened carrier may be displaced from the first position to the second position.

In these method embodiments, applying the second force further causes the plurality of sensor electronics carrier locking arms of the sensor electronics carrier to disengage from the sharp carrier and causes the retraction spring to expand. Disengaging the plurality of sensor electronics carrier locking arms from the sharp carrier may include positioning the plurality of sensor electronics carrier locking arms into a plurality of sheath notches of the sheath. Each of the plurality of sensor electronics carrier locking arms may be biased in a radially outward direction, and wherein the sheath notch may be configured to allow the plurality of sensor electronics carrier locking arms to expand in the radially outward direction. The retraction spring may be in a preloaded state prior to application of the second force, and wherein disengaging the plurality of sensor electronics carrier locking arms causes the retraction spring to expand in a proximal direction.

In these method embodiments, the retraction spring may be in a preloaded state prior to application of the second force, and wherein the retraction spring may include a first end coupled to the sharps carrier and a second end coupled to the sensor electronics carrier.

In these method embodiments, applying the second force further causes the drive spring to displace the sensor electronics carrier to the bottom of the applicator.

In these method embodiments, the analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in a bodily fluid of the subject.

In many embodiments, an applicator for inserting an analyte sensor into a subject is provided, the applicator comprising: a drive spring; a retraction spring; a sensor electronics carrier; a sharp carrier coupled to the sharp; and an analyte sensor; wherein the drive spring may be configured to displace the sensor electronics carrier and the sharp carrier from a first position within the applicator spaced from the skin surface to a second position adjacent the skin surface upon application of a first force to the applicator, and wherein a portion of the sharp and analyte sensor may be located below the skin surface and in contact with a bodily fluid of the subject at the second position, and wherein the retraction spring may be configured to displace the sharp carrier from the second position to a third position within the applicator and withdraw the sharp from the skin surface upon application of a second force to the applicator.

In these applicator embodiments, the application of the first force may comprise applying a force in a distal direction, and wherein the application of the second force may comprise applying a force in a proximal direction.

In these applicator embodiments, the applicator may further comprise a striker and a sheath, wherein the striker may be configured to disengage the one or more sheath tabs of the sheath from the one or more sensor electronics carrier latches of the sensor electronics carrier and cause the drive spring to expand upon application of the first force. The drive spring may be in a preloaded state prior to application of the first force, and wherein the drive spring may be configured to expand in a distal direction in response to disengagement of the one or more sheath tabs from the one or more sensor electronics carrier latches. The drive spring may be configured to receive an increased load before the striker disengages the one or more sheath tabs. The drive spring may be in a preloaded state prior to application of the first force, and wherein the drive spring may include a first end coupled to the striker and a second end coupled to the sensor electronics carrier.

In these applicator embodiments, the applicator may further comprise a sensor control unit coupled with the sensor electronics carrier, wherein a distal portion of the sensor control unit may be configured to contact the skin surface in the second position.

In these applicator embodiments, the applicator may further comprise one or more sensor electronics carrier tabs of the sensor electronics carrier configured to travel in a distal direction along the one or more sheath rails of the sheath between the first position and the second position.

In these applicator embodiments, the applicator may further comprise one or more sensor electronics carrier bumpers of the sensor electronics carrier configured to bias the inner surface of the sheath between the first position and the second position.

In these applicator embodiments, the applicator may further comprise a plurality of sensor electronics carrier locking arms of the sensor electronics carrier, wherein the sensor electronics carrier locking arms may be configured to disengage from the sharp carrier in response to application of the second force and cause the retraction spring to expand. The applicator may further comprise a plurality of sheath notches of the sheath, wherein the plurality of sheath notches may be configured to receive the plurality of sensor electronics carrier locking arms and cause the sensor electronics carrier locking arms to disengage from the sharp carrier. Each of the plurality of sensor electronics carrier locking arms may be biased in a radially outward direction, and wherein the sheath notch may be configured to allow the plurality of sensor electronics carrier locking arms to expand in the radially outward direction. The retraction spring may be in a preloaded state prior to applying the second force, and wherein the retraction spring may be configured to expand in a proximal direction when the plurality of sensor electronics carrier locking arms disengage from the sharp carrier.

In these applicator embodiments, the retraction spring may be in a preloaded state prior to application of the second force, and wherein the retraction spring may include a first end coupled to the sharp carrier and a second end coupled to the sensor electronics carrier.

In these applicator embodiments, the drive spring may be further configured to displace the sensor electronics carrier to the bottom of the applicator in response to application of the second force.

In these applicator embodiments, the analyte sensor may be an in vivo analyte sensor configured to measure the level of an analyte in a bodily fluid of a subject.

In many embodiments, the present invention provides an assembly for an applicator, the assembly comprising: a sharp module comprising a sharp portion and a hub portion, wherein the sharp portion may comprise a sharp shaft, a sharp proximal end coupled to the hub portion, and a sharp distal tip configured to penetrate a skin surface of a subject, wherein the sharp shaft comprises a sensor channel configured to receive at least a portion of an analyte sensor, wherein the sensor channel may be in a spaced relationship with the sharp distal tip, and wherein the sharp distal tip comprises an offset tip portion configured to create an opening in the skin surface.

In these assembly embodiments, the sharp module may further comprise a stainless steel material.

In these assembly embodiments, the sharp module may further comprise a plastic material.

In these assembly embodiments, wherein the offset tip portion may be further configured to prevent damage to the sensor tip portion of the analyte sensor during the sensor insertion process.

In these assembly embodiments, the cross-sectional area of the offset tip portion may be less than the cross-sectional area of the sharpened shaft.

In these assembly embodiments, the offset tip portion may include a separate element coupled to the sharpened shaft.

In these assembly embodiments, the sensor channel may include one or more sidewalls of the sharpened shaft. The offset tip portion may be formed from a portion of one or more sidewalls of the sharpened shaft. The sensor channel may include a first sidewall and a second sidewall, wherein the offset tip portion may be formed from an end of the first sidewall of the sharpened shaft, and wherein an end of the second sidewall may be proximate to the end of the first sidewall.

In many embodiments, methods of manufacturing an analyte monitoring system are provided, comprising: sterilizing a sensor sub-assembly comprising a sensor and a spike; assembling the sterilized sensor subassemblies into a sensor control device; assembling the sensor control device into an applicator; and packaging the applicator with the sensor control device therein for dispensing.

In these method embodiments, the sensor control device may be as shown in any one of fig. 20A-21G or substantially as shown in any one of fig. 20A-21G.

In these method embodiments, the applicator may be as shown in any one of fig. 22A-29G or substantially as shown in fig. 22A-29G.

In many embodiments, a method of manufacturing an analyte monitoring system is provided, the method comprising: assembling a sensor control device comprising a sensor and a sharp portion; assembling the sensor control device into an applicator; sterilizing an applicator having a sensor control device therein with a focused electron beam; and packaging the applicator with the sensor control device therein for dispensing.

In these method embodiments, the sensor control device may be as shown in any one of fig. 30A-31G or substantially as shown in fig. 30A-31G.

In these method embodiments, the applicator may be as shown in any one of fig. 32A-35G or substantially as shown in fig. 32A-35G.

It should be noted that all features, elements, components, functions, and steps described with respect to any embodiment provided herein are intended to be freely combined with and substituted for any other embodiment. If a feature, element, component, function, or step is described in connection with only one embodiment, it is to be understood that the feature, element, component, function, or step can be used with each other embodiment described herein unless explicitly stated otherwise. Thus, this paragraph can be readily introduced as a prerequisite basis for the claims and as a written support for combining features, elements, components, functions and steps in different embodiments or for replacing features, elements, components, functions and steps in an embodiment with those in another embodiment, even if the following description does not explicitly state that such combination or replacement is possible in certain circumstances. It is expressly recognized that express recitation of each possible combination and substitution is very burdensome, especially given the permissibility of each such combination and substitution will be readily recognized by those of ordinary skill in the art.

While the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and are herein described in detail. It should be understood, however, that these embodiments are not to be limited to the particular forms disclosed, but to the contrary, these embodiments are to cover all modifications, equivalents, and alternatives falling within the spirit of the disclosure. Furthermore, any feature, function, step, or element of the embodiments may be recited in or added to the claims, and the negative limitation of the scope of the invention of the claims may be defined by a feature, function, step, or element that is not within the scope of the claims.

Claims (22)

1. An assembly for an applicator, the assembly comprising:

a sharp module comprising a sharp portion and a hub portion, wherein the sharp portion comprises a sharp shaft, a sharp proximal end coupled to a distal end of the hub portion, and a sharp distal tip configured to penetrate a skin surface of a subject,

wherein the sharp portion further comprises a metallic material and is formed by a casting process.

2. The assembly of claim 1, wherein the sharp portion further comprises a stainless steel material.

3. The assembly of claim 1, wherein the sharp portion does not include a sharp edge.

4. The assembly of claim 1, wherein the sharp portion comprises one or more rounded edges.

5. The assembly of claim 1, wherein the sharp shaft comprises one or more rounded edges.

6. The assembly of claim 1, wherein the sharp shaft and the sharp distal tip comprise one or more rounded edges.

7. The assembly of claim 1, further comprising an analyte sensor, wherein the analyte sensor is an in vivo analyte sensor configured to measure an analyte level in a bodily fluid of the subject.

8. The assembly of claim 7, wherein a distal end of the analyte sensor is in a proximal position relative to the sharp distal tip.

9. The assembly of claim 7, wherein the distal end of the analyte sensor and the sharp distal tip are co-located.

10. The assembly of claim 7, wherein at least a portion of the analyte sensor is positioned within a sensor channel of the sharp shaft.

11. A method of maintaining structural integrity of a sensor control unit comprising an analyte sensor and a sensor module, the method comprising:

positioning a distal sensor portion of the analyte sensor below a skin surface and in contact with a bodily fluid, wherein the analyte sensor comprises a proximal sensor portion coupled to the sensor module, and wherein the proximal sensor portion comprises a hook feature adjacent to a capture feature of the sensor module;

receiving one or more forces in a proximal direction along a longitudinal axis of the analyte sensor; and

engaging the hook feature with the capture feature and preventing displacement of the analyte sensor in the proximal direction along the longitudinal axis.

12. The method of claim 11, further comprising loading the analyte sensor into the sensor module by moving the proximal sensor portion in a lateral direction to bring the hook feature into proximity with the capture feature of the sensor module.

13. The method of claim 12, wherein moving the proximal sensor portion in a lateral direction comprises moving the proximal sensor portion into a gap region of the sensor module.

14. The method of claim 11, wherein the one or more forces are generated by a sharp retraction process.

15. The method of claim 11, wherein the one or more forces are generated by a physiological response to the analyte sensor.

16. The method of claim 11, wherein the analyte sensor is an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.

17. A sensor control unit comprising:

a sensor module including a capture feature;

an analyte sensor comprising a distal sensor portion and a proximal sensor portion, wherein the distal sensor portion is configured to be positioned below a skin surface and in contact with bodily fluids, and wherein the proximal sensor portion is coupled to the sensor module and comprises a hook feature adjacent to the capture feature,

wherein the hook feature is configured to engage the capture feature and prevent displacement of the analyte sensor caused by one or more forces received by the analyte sensor and in a proximal direction along a longitudinal axis of the analyte sensor.

18. The sensor control unit of claim 17, wherein the sensor module is configured to receive the analyte sensor by moving the proximal sensor portion in a lateral direction and bringing the hook feature into proximity with the capture feature of the sensor module.

19. The sensor control unit of claim 18, wherein the sensor module further comprises a gap region configured to receive the proximal sensor portion when the proximal sensor portion is moved in a lateral direction.

20. The sensor control unit of claim 17, wherein the one or more forces are generated by a sharp retraction process.

21. The sensor control unit of claim 17, wherein the one or more forces are generated by a physiological reaction to the analyte sensor.

22. The sensor control unit of claim 17, wherein the analyte sensor is an in vivo analyte sensor configured to measure an analyte level in the bodily fluid of the subject.

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